Medtronic Statement Regarding Senate Hearings on Industry And Physician Relationships

In advance of hearings on Wednesday, February 27, in the Senate Special Committee on Aging, Medtronic, Inc. (NYSE:MDT), today issued the following statement:

On Wednesday, February 27, the Senate Special Committee on Aging will explore relationships between industry and physicians and consider the proposed “Sunshine Act” (S.2029) introduced earlier this year by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI).

The Sunshine Act would require industry to publicly disclose via the Internet certain payments made to physicians in return for their time and expertise with product development, research and training. For decades, the innovative power and clinical expertise of physicians have produced technologies that industry has brought to patients around the world, and Medtronic believes these vital collaborations must be protected

The Sunshine Act is aimed at curbing inappropriate relationships or conflicts of interests between industry and physicians, an effort that Medtronic – one of the world’s leading medical technology companies – supports.

Medtronic believes, however, the bill can and should go even further by requiring the same level of disclosure by all companies in the industry, regardless of size and including those companies owned in whole or in part by physicians. Companies with yearly revenues less than $100 million and physician-owned companies are currently excluded from the bill, and they account for more than 75 percent of the companies in the industry.

Medtronic believes a level playing field for all companies is appropriate and that these entities should operate under the same disclosure requirements, recognizing that transparency can help alleviate any real or perceived conflicts of interest with these types of companies as well.

“We have been pleased to work with the members of the Senate Special Committee on Aging, the Senate Finance Committee, and members of the House of Representatives and Senate on this legislation,” said Bill Hawkins, president and CEO of Medtronic. “We will continue to work with the sponsors of this legislation to incorporate all companies in the industry into the bill and bring greater transparency to these important relationships.”

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Medtronic Announces Exclusive Licensing of Arbor Surgical Technologies Pericardial Heart Valve

Medtronic, Inc. (NYSE:MDT) and Arbor Surgical Technologies, Inc. today announced an exclusive global licensing agreement under which Medtronic will manufacture, market and distribute Arbor’s bovine pericardial tissue heart valve technologies. In addition, Medtronic has acquired a minority stake in Arbor. Arbor retains its exclusive rights to the modular Trilogy™ Aortic Valve System and sutureless TRE™ implantation technologies.

“We are optimistic that Arbor’s pericardial valve design combined with Medtronic’s proprietary technologies will achieve best-in-class performance. I am truly excited about this opportunity and the ongoing strengthening of our Structural Heart Disease product offering.” said Dr. John Liddicoat, vice president and general manager of the Structural Heart Disease business at Medtronic, “No other comparable technology exists today.” Dr. Thomas Fogarty, Arbor’s chairman and co-founder, added, “I am pleased to be partnering with a company like Medtronic that has the ability to bring our technology to so many patients.”

The technology will complement Medtronic’s Structural Heart Disease therapy objectives, which are focused on developing effective options for valve disease, septal defects and atrial fibrillation. Medtronic anticipates that development of Arbor's technology will enable future pericardial valves to achieve similar industry-leading patient survival outcomes as has been achieved with the highly successful Hancock II® and third-generation Mosaic® and Freestyle® porcine valves. The company will continue to enhance its line of third-generation porcine valves, as well as invest in its transcatheter valve program. Medtronic anticipates manufacturing the valve in its existing production facilities.

Arbor’s heart valve technology was created by valve inventor Ernie Lane, designer of multiple pericardial valves currently on the market, to address several known failure modes exhibited in existing pericardial valve designs. “I was not satisfied with the durability of the existing pericardial valves and felt there to be room for improvement,” said Mr. Lane, Arbor’s co-founder. Arbor’s technology will facilitate the development of Medtronic’s first pericardial valve, which will complement its portfolio of porcine and mechanical heart valves.

According to the Millennium Research Group, more than 106,000 heart valves are expected to be implanted in the in the U.S. in 2008.

About Medtronic
Medtronic, Inc., (www.medtronic.com) headquartered in Minneapolis, is the world’s leading medical technology company, alleviating pain, restoring health and extending life for people with chronic disease.

About Arbor
Arbor Surgical Technologies, Inc., (www.arborsurgical.com) with facilities in Irvine and Portola Valley, CA (USA), is a privately held cardiovascular device company focused on the minimally invasive heart valve replacement market. Founded in 2002 by Dr. Thomas J. Fogarty and noted heart valve designer, Ernie Lane, Arbor is developing technologies intended to deliver significant clinical benefit to patients worldwide. The Trilogy™ Aortic Valve System and TRE™ attachment systems are designed to expand the use of minimally invasive heart valve procedures.

Medtronic Launches AneuRx AAAdvantage Stent Graft on New Xcelerant® Hydro Delivery System in U.S for Minimally Invasive Treatment of Abdominal Aortic

Continuing its record of innovation in endovascular therapies for aortic aneurysms, Medtronic, Inc. (NYSE: MDT), today announced the U.S. market launch of the AneuRx AAAdvantage® Stent Graft on the new Xcelerant® Hydro Delivery System, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. In addition, Medtronic has also received approval from the U.S. Food and Drug Administration to introduce its latest generation of packaging materials for the launch of this product.

Present in an estimated 1.2 million people in the United States, an abdominal aortic aneurysm (AAA) is a dangerous bulge or weakening of the body’s main artery that can rupture with fatal consequences if left untreated. If detected before rupturing, AAAs with diameters of more than twice the size of the normal infrarenal aorta are typically treated with either open surgical repair or endovascular repair (EVAR). In contrast to open surgical repair, EVAR involves a minimally invasive procedure in which a tube-like sleeve called a stent graft is threaded through the femoral artery in a compressed state on a delivery system and expanded inside the aorta at the site of the aneurysm. Once in place, the sleeve creates a new path for blood flow, reducing pressure on the aneurysm. The delivery system is then removed. EVAR has been shown to be an effective therapy for AAA, with fewer post-operative complications and shorter recovery times than open surgical repair.

“The Xcelerant Hydro Delivery System is a significant innovation that will make endovascular repair using the AneuRx AAAdvantage Stent Graft a treatment option for more patients with abdominal aortic aneurysms,” said Dr. Frank R. Arko, M.D., chief of Endovascular Surgery at the University of Texas Southwestern Medical Center in Dallas. “It will simplify the procedure for endovascular interventionalists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous.”

The Xcelerant Hydro Delivery System will be used with the AneuRx AAAdvantage Stent Graft, which was introduced in the United States in March 2006. In bench testing, the Xcelerant Hydro Delivery System was shown to generate 68 times less friction than the previous delivery system, which does not have the hydrophilic coating. Hydrophilic means “affinity for water”; because water is a major component of blood, the hydrophilic coating is designed to ease the delivery system’s passage through the artery.

In addition, the Xcelerant Hydro Delivery System features a uniquely integrated sheath that is tapered on both ends. This dual-taper sheath is designed to facilitate insertion and retraction of the entire delivery catheter by minimizing the time that the surface area of the sheath is in contact with the artery wall. The integrated sheath also contributes to the system’s low profile characteristics, which are intended to enable excellent tracking and access through small vessels.

“Experience remains the foundation of our innovations in endovascular therapy, and the Xcelerant Hydro Delivery System represents our latest innovative contribution to this exciting field,” said Katie Szyman, vice president and general manager of Medtronic’s Endovascular Innovations business. “Combined with the AneuRx AAAdvantage Stent Graft, Medtronic now offers U.S. endovascular physicians an even stronger option for their EVAR procedures.”

Medtronic has been an innovator and leader in the endovascular stent graft industry for more than a decade, as evidenced by more implants than any other company. Its long history includes more than 100,000 patients treated with aortic stent grafts dating back to 1995. Medtronic currently offers the broadest portfolio of endovascular stent grafts in the industry. These include the AneuRx AAAdvantage Abdominal Stent Graft System in the United States, and the Talent Abdominal, Talent Thoracic and Valiant Thoracic Stent Graft Systems outside the United States.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic and Weigao Announce Joint Venture in China

Medtronic, Inc. (NYSE:MDT) (“Medtronic”) and Shandong Weigao Group Medical Polymer Company Limited (Hong Kong Stock Exchange: 8199) (“Weigao”) today announced that they have agreed to form a joint venture to market therapies in the spine and orthopedics sector and that Medtronic would acquire a 15% equity interest in Weigao.

The joint venture will market in China Medtronic’s spinal products and Weigao’s orthopedic products which include therapies for the hip, shoulder, spine and trauma. Under the joint venture agreement (“Joint Venture Agreement”), Medtronic will have a 51% interest in the joint venture and Weigao will have a 49% interest.

Medtronic will purchase a 15% equity interest in Weigao for approximately HK$1,726 million (US$221 million) through the purchase of 80,721,081 newly issued H Shares of Weigao that are listed on the Hong Kong stock Exchange at a purchase price of HK$11.138 per share and an equal number of Weigao’s unlisted ordinary shares from Weigao’s existing shareholders at a purchase price of HK$10.247 per share. In connection with the purchase of the shares, Medtronic will have the right to nominate two non executive directors to Weigao’s board of directors as long as Medtronic owns 3.75% of the H Shares.

Closing of the transaction is subject to various conditions, including approval of the Chinese regulators and Weigao’s shareholders.

“China is key to our global strategy as we continue to expand our geographic footprint,” said Bill Hawkins, Medtronic president and CEO. “Weigao has a broad orthopedic and trauma product line that compliments Medtronic’s offerings, but even more importantly, we feel we can generate synergies with their very strong presence and reputation in China. We view Weigao as an ideal strategic partner.”

Mr. Chen Xue Li, chairman of Weigao said, “We take great pride in forming a strategic alliance with Medtronic, the world’s leading medical technology company. The collaboration will further broaden our business and raise our R&D capability, leveraging our extensive customer network and quality production, paving the way for Weigao to be the leading medical device company in Asia. With our localized knowledge, we hope to play an important role in Medtronic’s China strategy bringing Medtronic’s products to benefit millions of patients in China.”

About Medtronic
Medtronic, Inc., (www.medtronic.com) headquartered in Minneapolis, is the world’s leading medical technology company, alleviating pain, restoring health and extending life for people with chronic disease. Its Internet address is.

About Weigao
Weigao (www.weigaogroup.com) based in the Shandong province of the People’s Republic of China, is the leading manufacturer in China of medical devices and single-use consumables including infusion sets, syringes, blood transfusion sets and blood bags as well as orthopedic, cardiovascular stent and blood purification products.

Medtronic Implantable Cardiac Monitors Give Physicians Valuable Insights Into Heart Rhythms

Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) clearance of the Reveal® DX and Reveal® XT, new Insertable Cardiac Monitors (ICMs) that offer unique diagnostic and monitoring insights to cardiologists managing their patients with syncope (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole. The new Reveal devices expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal® and Reveal Plus® Insertable Loop Recorders. The Reveal DX will be commercially available in the United States beginning next week; the Reveal XT will follow.

The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown¹. It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.

“The Reveal DX showcases Medtronic’s commitment to providing answers to patients with previously unidentified arrhythmias,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business at Medtronic. “These patients often have their lives and activities curtailed because of unexplained fainting episodes. The Reveal monitors provide diagnostics and monitoring that can offer physicians a view into their patients’ conditions even when they’re not present.”

Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the Reveal DX monitor records important cardiac rhythm data, which may help a physician to diagnose the patient so the appropriate treatment can be undertaken. The device weighs just 15 grams and is approximately the size of a memory stick; unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads (tiny wires) that extend from the device into the heart’s chamber(s). To store an electrocardiogram (ECG) at the time of an episode, a patient places a hand-held, pager-sized activator over the device, and presses a button. Later a physician analyzes the stored information and determines if the episode was caused by an abnormal heart rhythm.

¹E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885

About Arrhythmias
Arrhythmias are simply irregular heart rhythms in the heart’s atria (upper chambers) or ventricles (lower chambers). They can be dangerously fast heart rhythms, known as tachycardia or tachyarrhyhmias; dangerously slow rhythms, known as bradycardia or bradyarrhythmias; fibrillation, where the heart quivers instead of pumping blood effectively to the body; or asystole, which is the absence of electromechanical activity within the heart.

About Medtronic
Medtronic, Inc. (www.medtronic.com ), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic Receives FDA Marketing Clearance for Complete SE Biliary Stent System

Medtronic, Inc. (NYSE: MDT), announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the Complete SE (self-expanding) Biliary Stent System, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree – cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids.

U.S. commercial sales of the new biliary stent will begin immediately in a wide size range, with diameters of 4 – 10 mm and lengths of 20 – 150 mm.

Bench testing has shown the Complete SE Biliary Stent System to be extremely accurate in terms of stent placement. Accurate stent placement can decrease the likelihood that additional stents are necessary to cover the entire narrowing of the bile duct.

The safety and effectiveness of this device in the vascular system have not been established.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic Trials Confirm Ability of Interceptor Coronary Filter System and Export® Aspiration Catheter to Reduce Major Cardiac Events

Reflecting its commitment to patient safety and ongoing medical research, Medtronic, Inc. (NYSE: MDT), today announced the findings from two clinical trials highlighting the ability of next-generation technologies to improve patient outcomes following interventional procedures. Results of the AMEthyst and EXPORT trials were presented this week at the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The AMEthyst trial was an 800-patient, U.S.-based multicenter, randomized trial to evaluate the safety and efficacy of the Interceptor PLUS Coronary Filter System as an adjunct to percutaneous interventions on saphenous vein bypass grafts (SVGs). The findings demonstrate that when compared to commercially available control devices (Medtronic’s Guardwire® Temporary Occlusion Balloon and Boston Scientific’s Filterwire EZ™), Medtronic’s new Interceptor PLUS Coronary Filter System works equally well in reducing major adverse cardiac events (MACE).

Medtronic also announced new findings from the EXPORT trial, a study assessing the safety and efficacy of the Export Aspiration Catheter, a device designed to remove thrombus and embolic material that is present in many blood vessel lesions and may become dislodged during interventional procedures. The study, a randomized, controlled trial of 250 patients at 24 sites in Europe and India comparing the use of Export prior to stent implantation with conventional stenting in patients with acute myocardial infarction (AMI), demonstrated the effectiveness of the Export Aspiration Catheter in improving blood flow in AMI patients.

Interceptor PLUS
A significant number of U.S. patients undergo coronary artery bypass grafting (CABG) procedures each year. The improved blood flow gives patients a new lease on life but, unfortunately, approximately half of these grafts can also become blocked or diseased over time. Moreover, they can become blocked by fragile, brittle and “friable” atheromous material as they age. When this occurs, cardiologists perform stent angioplasty to keep blood flowing through the vein grafts – a process that can also release showers of embolic debris. Embolic debris, if not contained, can flow downstream to result in blockages of tiny tributary vessels and trigger “microinfarcts,” or tiny heart attacks that destroy areas of heart muscle.

The Medtronic Interceptor PLUS Coronary Filter addresses this problem through its unique design. A braided nitinol filter mounted on a 0.014” hypotube, Interceptor PLUS is delivered in a closed state into the artery, moved past the blockage and opened before performing conventional stent angioplasty. The Interceptor PLUS Coronary Filter maintains blood flow in saphenous vein grafts while trapping the embolic debris.

Data from the AMEthyst trial showed that Interceptor PLUS met the primary study endpoint to demonstrate safety, MACE at 30 days, indicating non-inferiority of Interceptor PLUS compared to control devices. Interceptor PLUS also demonstrated efficacy with device success over 90 percent and a low incidence of clinical failure when compared to commercially available control devices. Medtronic’s successful completion of this study enables the company to pursue 510(k) clearance with the FDA to market the device in the U.S.

Export XT
Cleared for use in the U.S. in 2006, the Export XT Aspiration Catheter design allows for superior deliverability in even the most demanding cases. The full-wall variable braiding design helps eliminate segment joints and weak points in the catheter to improve kink resistance, and allows enhanced deliverability due to seamless transition of shaft stiffness from one end of the catheter to the other. The device features a soft tip material with a short, beveled design for minimal vessel trauma and improved debris capture, plus a hydrophilic coating for greater lubricity. Since its introduction in 2001, the Export Aspiration Catheter product line has been used to remove embolic debris in more than 200,000 patients worldwide.

Data from the EXPORT trial found Export met its primary endpoint. In patients presenting with an AMI, primary aspiration using the Export Aspiration Catheter is associated with a higher percentage of patients with ST segment resolution of greater than 50 percent at 60 minutes post procedure and/or a myocardial blush grade III immediately post-procedure than in patients with conventional stenting. In addition, primary aspiration using the Export catheter is associated with a lower rate of no-flow, higher corrected TIMI frame count post procedure, and a lower requirement for bail-out techniques.

“These trials demonstrate the Medtronic commitment to innovate new technologies that are specifically designed to reduce the risks associated with interventional procedures,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral business at Medtronic. “The performance of these new devices is well characterized and represents a significant advance in interventional cardiology.”

About Medtronic
Medtronic, Inc. (http://www.medtronic.com/ ), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic and Kyphon Announce Clearance from German Federal Cartel Office for the Merger of Medtronic and Kyphon

Medtronic, Inc. (NYSE: MDT) and Kyphon Inc. (Nasdaq: KYPH) announced today that the German Federal Cartel Office has given its clearance in connection with the previously announced merger agreement between Kyphon and Medtronic, Inc. Completion of the transaction, which is expected later this year or in the first quarter of 2008, remains subject to obtaining approvals of antitrust authorities in several other jurisdictions, the approval of Kyphon’s stockholders and other customary closing conditions. A special meeting of Kyphon’s stockholders to vote on the proposed merger has been called for October 16, 2007. If further antitrust clearances are obtained prior to the Kyphon stockholders' meeting, the companies will provide an update at the time of the meeting.


ABOUT MEDTRONIC
Medtronic, Inc. (http://www.medtronic.com/), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.


Medtronic is a registered trademark of Medtronic, Inc.


ABOUT KYPHON
Kyphon develops and markets medical devices designed to restore and preserve spinal function and diagnose the source of low back pain using minimally invasive technologies. The company’s products are used in balloon kyphoplasty for the treatment of spinal compression fractures caused by osteoporosis or cancer, in the Functional Anaesthetic Discography™ (F.A.D.™) procedure for diagnosing the source of low back pain, and in the Interspinous Process Decompression (IPD®) procedure for treating the symptoms of lumbar spinal stenosis. More information about the company and its products can be found at http://www.kyphon.com/ and its balloon kyphoplasty patient education Web site, http://www.spinalfracture.com/.


Kyphon and IPD are registered trademarks, and Functional Anaesthetic Discography and F.A.D. are trademarks, of Kyphon Inc.

Survey Indicates Meniett Therapy Is Preferred Treatment, After Diet Modification, for Management of Meniere's Disease

Results of a survey published in the August 2007 issue of Otology & Neurotology indicates that the Meniett® Low Pressure Pulse Generator manufactured by Medtronic, Inc. (NYSE: MDT) is the preferred treatment method after diet modification for patients diagnosed with Ménière's Disease in an only hearing ear. The survey was conducted among a nonrandom sample of clinically active members of the American Otological Society and the American Neurotology Society by researchers from the Division of Otolaryngology – Head and Neck Surgery at Penn State Milton S. Hershey Medical Center.


Dietary modification was recommended as first-line therapy by 99 percent of the survey respondents, including moderate to strict salt restriction, decreased caffeine intake and avoidance of alcohol. A diuretic was also recommended by 96 percent of respondents.

When asked what they would offer if initial treatment failed, respondents chose the Meniett® device first and most frequently over therapies such as intratympanic corticosteroids, endolymphatic sac mastoid shunt, intratympanic gentamicin perfusion and endolymphatic sac vein decompression.

“We agree that the Meniett® makes the most sense as the second-line treatment of choice for this difficult problem. It has demonstrative efficacy and a low-risk profile,” stated Jon Isaacson, M.D., associate professor of Surgery and director of Otology/Neurotology at Penn State Milton S. Hershey Medical Center and co-conductor of the survey.

Approximately 2.6 million people in the United States and Europe1 suffer from Ménière’s disease, a disorder associated with excess fluid in the inner ear. This complex disease is characterized by vertigo in combination with hearing loss, tinnitus (ringing in the ear) and pressure in the ear. The origin is unknown and there is no cure, which makes managing the disease difficult when symptoms are severe. Unpredictable vertigo attacks with nausea and vomiting can be very debilitating, with patients unable to work or perform routine activities.2


About the ENT Business at Medtronic

Located in Jacksonville, Fla., the ENT business at Medtronic (www.MedtronicENT.com) is a leading developer and manufacturer of products to treat diseases of the ear, nose and throat (ENT). Patients seeking additional information about Ménière’s disease and the Meniett device should visit www.meniett.com.


About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

1. Stahle J, Stahle C, Arenberg IK. The incidence of Ménière’s disease. Arch Otolaryngol Head Neck Surg. 1978;104:99-102.

2. Anderson JP and Harris JP. Impact of Ménière’s disease on quality of life. Otol Neurotol. 2001;22:888-894.

Medtronic to Acquire Kyphon for $3.9 Billion

Medtronic, Inc. (NYSE: MDT) and Kyphon (NASDAQ: KYPH) today announced that the companies have signed a definitive merger agreement under which Medtronic will acquire all of the outstanding shares of Kyphon for $71 per share in cash. The transaction, which was unanimously approved by the boards of directors of both companies, is valued at approximately $3.9 billion. This excludes $320 million in payments associated with the St. Francis Medical Technologies, Inc. and Disc-O-Tech Medical Technologies, Ltd. transactions.

The acquisition price represents a 32% premium over Kyphon’s closing stock price on July 26, 2007 of $53.68 and a 35% premium over Kyphon’s 30-day average trading price of $52.76 per share. The transaction, which is anticipated to close in the first calendar quarter of 2008, is expected to be neutral to Medtronic earnings in the first full fiscal year after closing and accretive thereafter. Medtronic expects the merger to yield significant revenue, cost and tax synergies.

“We expect our combination with Kyphon to help accelerate the growth of Medtronic’s existing spinal business by extending our product offerings into some of the fastest growing product segments and enabling us to provide physicians with a broader range of therapies for use at all stages of the care continuum,” said Art Collins, chairman and chief executive officer of Medtronic. “Importantly, the combination will also enable more patients of all ages to receive the benefits of modern, minimally invasive spinal treatments earlier in their care, with life-style friendly options that are simpler, faster and less invasive than many traditional surgical treatments.

“We have great respect for Rich Mott and his team and look forward to Kyphon’s employees joining Medtronic at the close of the transaction. Kyphon’s world-class, global sales force will play a central role in the continued development of our spinal business,” Collins concluded.

“We are very enthusiastic about the opportunity to deliver outstanding value for our shareholders that fully reflects Kyphon’s innovation and growth potential. This merger also combines two recognized industry leaders in spinal treatments,” said Richard Mott, president and chief executive officer of Kyphon. “By merging our complementary strengths and collective resources into one organization, we will meaningfully increase our ability to ensure we meet the needs of our clinician customers around the world and the patients they serve. This combination also offers our employees the opportunity to become part of an organization with a shared vision and the depth of resources that are increasingly beneficial for sustained success in our industry. We look forward to working with Medtronic to complete the transaction quickly and seamlessly. Our board of directors believes that this acquisition is in the best interests of our shareholders, employees and other stakeholders and has unanimously voted to recommend that Kyphon shareholders vote in favor of it.”

The two companies’ product lines and geographic presence are highly complementary. While both companies have expertise in minimally invasive, highly effective treatments, Medtronic’s spinal surgery focus has been on providing treatment options for younger patients who are suffering from scoliosis and degenerative disc disease in the cervical and lumbar spine. Kyphon’s focus has been on treating older patients suffering from vertebral compression fractures and spinal stenosis. Together, the combined entity will be able to leverage its knowledge of modern fusion, dynamic stabilization, artificial disc replacement, biologics, vertebral augmentation, interspinous process decompression, disc disease diagnosis, navigation and minimally invasive techniques to serve patients with a broader variety of spinal disorders in order to alleviate pain and restore health for more patients.

The combined entity will also have a larger and expanded base of customers than Medtronic serves alone. Medtronic primarily serves orthopaedic and neurological surgeons who specialize in spinal surgery. Kyphon serves these same physicians and also has a significant customer base with interventional radiologists and interventional neuroradiologists.

The transaction will be financed by a combination of cash on the balance sheet and debt.

The transaction is subject to customary closing conditions, including approval by antitrust regulators as well as Kyphon shareholders.

Cleary Gottlieb Steen & Hamilton LLP is acting as legal advisor to Medtronic and Goldman, Sachs & Co. and Piper Jaffray are acting as financial advisors. Latham & Watkins LLP is acting as legal advisor to Kyphon and JPMorgan is acting as financial advisor.

Analyst Conference Call/Webcast
Medtronic and Kyphon will host an investor conference call (612-332-1210) later this morning at 7:30 a.m. central time (5:30 a.m. pacific time) to discuss the Kyphon acquisition. For complete instructions on how to participate in the conference call, or to listen to the live audio webcast or a replay of the webcast, please refer to the Investor Relations sections at http://www.medtronic.com or http://www.kyphon.com.

ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

ABOUT KYPHON INC.
Kyphon develops and markets medical devices designed to restore and preserve spinal function and diagnose the source of low back pain using minimally invasive technologies. The company’s products are used in balloon kyphoplasty for the treatment of spinal compression fractures caused by osteoporosis or cancer, in the Functional Anaesthetic Discography™ (F.A.D.™) procedure for diagnosing the source of low back pain, and in the Interspinous Process Decompression (IPD®) procedure for treating the symptoms of lumbar spinal stenosis. More information about the company and its products can be found at www.kyphon.com and its patient education Web site, www.spinalfracture.com.

Medtronic Announces Agreement with Spinal Neuromonitoring Innovator

Medtronic, Inc. (NYSE: MDT) today announced it has entered into a distribution and development agreement with Axon Systems, a privately-held developer of neuromonitoring technology used during spinal surgery. The agreement will allow Medtronic and Axon Systems to bring to market the next generation of surgeon directed and professionally supported spinal neuromonitoring technology and expand the availability of this critical technology.

This agreement will have an immediate impact on Medtronic’s spinal neuromonitoring product line and sets the stage for possible integration across all of Medtronic's core spinal therapy offerings.

The first new products enabled by this strategic alliance will be the NIM-ECLIPSE™ Spinal System of neuromonitoring capital and disposable equipment. NIM-ECLIPSE received 510k clearance in the U.S. in May 2006. This equipment will allow for as many as 32 channels of simultaneous electroencephalography (EEG), evoked potentials (EP) and electromyography (EMG) monitoring. NIM-ECLIPSE™ Spinal System also provides for automatic pedicle screw monitoring with direct nerve and screw stimulation. During spinal surgery, the NIM-Eclipse may allow physicians to monitor critical neural pathways which helps prevent post-operative neurological deficits.

“We are extremely excited about our relationship with Axon Systems and the opportunity to improve the availability of intraoperative spinal neuromonitoring service and technology,” said Pete Wehrly, senior vice president and president of the Spinal and Biologics businesses at Medtronic. “Axon Systems has been a neuromonitoring technology innovator and leader since 1987 and our partnership will enable us to better integrate neuromonitoring technology into Medtronic’s core spinal therapies.”

“Working with Medtronic is a wonderful opportunity for us to improve our abilities of how best to deliver and integrate neuromonitoring technology and techniques into surgical procedures that place the spinal nervous system at risk,” said Howard Bailin, founder and COO of Axon Systems.

About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at http://www.medtronicspinal.com/ and its patient-education Web sites, http://www.back.com/ , http://www.iscoliosis.com/ , http://www.maturespine.com/ and http://www.necksurgery.com/.

About Medtronic
Medtronic, Inc. (http://www.medtronic.com/), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

About Axon Systems
Axon Systems, founded in 1987, is a leading manufacturer of neurological intraoperative (NIOM) and intensive care monitors. Its products are used in operating rooms to monitor critical neural pathways during surgery, aiding surgeons and helping to prevent post-operative neurological deficits. In the intensive care unit Axon products are used for diagnostic long-term monitoring and to provide prognostic information and guiding patient care. More information about the company and its products can be found at http://www.axonsystems.com/

Medtronic Completes Implants in SANTE Trial of Deep Brain Stimulation for Epilepsy

Medtronic, Inc. (NYSE: MDT), today announced the completion of implants in its U.S. pivotal clinical study of deep brain stimulation (DBS) for the treatment of medically refractory epilepsy, a form of the neurological condition that does not respond to antiepileptic drugs. With 110 patients now implanted with the Intercept™ Epilepsy Control System, results of the study – the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) Trial – are expected to be available during 2008.

Ongoing at 17 medical centers in the United States, the SANTE Trial is using existing Medtronic DBS technology to determine whether bilateral stimulation of the anterior nucleus of the thalamus – the brain’s central message and relay station – can safely and effectively reduce seizure frequency in people with epilepsy. The same technology is approved for treating motor symptoms of Parkinson’s disease and essential tremor – the two most common movement disorders. It has been used by more than 40,000 people worldwide, however, Medtronic’s DBS therapy has not yet been approved for use in medically refractory epilepsy. Unlike other treatments that involve brain surgery, DBS therapy is non-destructive, adjustable and reversible.

All implanted patients in the SANTE Trial will be monitored for 13 months following implant, with long-term follow-up continuing until the device is approved for treating epilepsy or the study is stopped. Trial participants are adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. (Individuals with partial-onset epilepsy have seizures that originate in a localized area of the brain.) To qualify for enrollment, study patients were required to have had an average of six or more seizures per month. They continue to receive their epilepsy medications while participating in the trial.

“Despite best medical management, a significant proportion of people with epilepsy continue to experience seizures that wreak havoc on their lives,” explained the trial’s principal investigator, Dr. Robert Fisher, professor of neurology and director of Stanford Epilepsy Center at Stanford University in Palo Alto, Calif. “For this underserved patient population, deep brain stimulation may represent a promising new treatment option.”

According to the Epilepsy Foundation, epilepsy and seizures affect more than three million Americans of all ages, at an estimated annual cost of $12.5 billion in direct and indirect costs. Despite trying a range of treatment options, about one-third of people with epilepsy continue to experience debilitating, recurring seizures – brief periods of abnormal electrical activity in the brain. The unpredictability of seizures affects daily activities and disrupts school days, work responsibilities and social functioning.

“The SANTE Trial is one of several major studies that Medtronic is sponsoring or supporting to establish compelling clinical evidence for approved and investigational applications of our neuromodulation technologies, which include implantable neurostimulation systems and site-specific drug-delivery systems,” said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the Neuromodulation business unit. “With this latest milestone complete, we are one step closer to understanding the effectiveness of DBS therapy for patients with medically refractory epilepsy.”

Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis.

ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic Insertable Heart Monitor Gives New Insight Into Heart Rhythm Disorder

Today Medtronic, Inc. (NYSE: MDT) announced the European introduction of Reveal® XT, the first Insertable Cardiac Monitor that offers long-term and continuous monitoring of Atrial Fibrillation (AF). All other current monitoring tools are either for a limited period or on an intermittent basis. Long-term, continuous monitoring means that a clinician no longer needs to rely only on incomplete data to evaluate how AF may be progressing or treatment effectiveness. The device recently received CE (Conformité Européenne) Mark, and the first implant of Reveal XT took place at Asklepios Klinik St. Georg in Hamburg, Germany by Prof. Karl-Heinz Kuck, M.D. The Reveal XT insertable cardiac monitor is not currently available for sale in the United States.

AF is the most common cardiac arrhythmia, experienced by 4.5 million patients in Europe1. Treatment of AF is difficult as episodes often show no symptoms and therefore go unnoticed by patients2. Yet the risks are well known – AF can lead to a two to seven times higher risk of stroke1, an increased risk of heart failure and sudden cardiac death3 due to inefficient pumping in the heart.

“Atrial fibrillation is the most frequent cardiac arrhythmia. It is often accompanied by symptoms that are very unpleasant for the patient,” said Prof. Kuck, Hanseatisches Herzzentrum / Department of Cardiology, Asklepios Klinik St. Georg. “Moreover, atrial fibrillation is linked with increased mortality and an increase in the incidence of stroke, by a factor of two- to seven-fold. However, with the new Reveal XT, atrial fibrillation can now be scrutinized over a period of three years with a subcutaneous monitor. This gives us totally new possibilities for monitoring and adjusting the treatment.”

The Only Way of Precisely Treating AF Is Knowing AF
The Reveal XT Insertable Cardiac Monitor monitors AF patients 24 hours a day, every day for up to three years. There are a variety of ways to treat AF, but up until now physicians had no means of gathering detailed data, over an extended period, on the progression of AF and the effect of treatment. Reveal XT gives new insight into patients’ heart rhythms, which may help physicians to evaluate stroke risk and determine appropriate treatment and therapy options for their patients.

24/7 Monitoring Provides Patient Compliance
As Reveal XT is inserted just under the skin, the patient experiences no restrictions in daily activities. This is not only more comfortable for the patient, but also ensures that cardiac data recorded is not influenced by restrictions in activities. Patients continue to lead their normal life and therefore heart activity recorded shows real-life, relevant information. Once patients leave the clinic, Reveal XT does not require wires or sticky pads to monitor the patients’ heart rhythms.

1 ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation
2 T. Fetsch, EHJ. 2004;1385-1394
3 A. Krahn et al. Am J Med. 1995; 98:476-484

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

New Medtronic Implantable Cardiac Monitor Gives Physicians Valuable Insights Into the Cause of Unexplained Fainting

Medtronic, Inc. (NYSE: MDT) today announced the European introduction of the Reveal® DX, a new Insertable Cardiac Monitor that offers diagnostic and monitoring information related to syncope (fainting) in patients. The device recently received CE (Conformité Européenne) Mark, and the first implant of Reveal DX took place at Ospedali del Tigullio in Lavagna, Italy, by Prof. Michele Brignole, M.D. Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the monitor records important data before, during and after a syncopal event. This data enables the physician to diagnose the patient and determine the right treatment based on long-term cardiac rhythm trend data. The Reveal DX insertable cardiac monitor is not currently available for sale in the United States.

Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown¹. It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.

With the information obtained from the Reveal DX, the physician can understand if the cause of syncope is cardiac related, which may help to appropriately manage the patient’s arrhythmia.

“Syncope can cause a considerable degree of anxiety and activity restrictions for people,” said Prof. Brignole of the Department of Cardiology, Ospedali del Tigullio. “Application of this insertable cardiac monitor helps me to diagnose the underlying cause of syncope so that I can treat my patients appropriately.”

Always on Watch
The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Reveal DX is the only insertable cardiac monitor that can record an ECG at the time of a syncopal episode.

¹E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

New Patient Monitoring System Allows Routine Checkups of Deadly Heart Conditions Using the Internet

The future of medical device technology took a major step forward today as Medtronic, Inc. (NYSE: MDT) announced the European launch of a new heart monitoring system at EUROPACE, a major educational and research meeting in arrhythmias and cardiac pacing held this week in Lisbon, Portugal. The Medtronic CareLink® Network, Monitor and software will enable patients at risk of heart conditions to electronically transmit data from their implanted cardiac device directly to their physician, allowing the completion of life-saving check-ups without requiring the patient to leave home.

Approximately 500,000 patients die from sudden cardiac death (SCD) in Europe each year1; most of these deaths are caused by the heart beating abnormally (arrhythmias). These abnormal heart rhythms are triggered by a fault in the heart’s electrical system, causing the heart to beat rapidly (ventricular tachycardia), slowly (bradycardia) or irregularly (ventricular fibrillation). Implantable cardioverter-defibrillators (ICDs) are medical devices that are implanted in the chest area with leads (wires) extending to the heart, where they administer electrical therapies to stop the dangerous ventricular arrhythmias that can lead to sudden cardiac death. Up to 2 million patients in Europe are candidates for ICDs2; since ICDs are proven to be 98 percent effective3, this suggests a number of lives could be saved with their use.

Patients with ICDs need regular check-ups to monitor the function of their device. The Medtronic CareLink Network is an Internet-based monitoring service which connects such patients and their physicians for “virtual check-ups.” Patients simply hold a small antenna over their device, and information on how their heart and ICD are working, which is comparable to the information provided during an in-clinic follow-up visit, is downloaded into the Medtronic CareLink Monitor. This information is then sent through a telephone line directly to a new data centre in Europe. Clinicians can access their patients’ data by logging onto a secure physician Web site, and may make adjustments to the patient’s medication or prescribe additional therapy without needing to see the patient in person.

Until now, people living with an ICD faced two to four scheduled visits to their clinic each year for a device check-up, with potentially unscheduled visits as needed for more critical situations. Now, the small and easily portable Medtronic CareLink Monitor allows patients to stay connected to their clinicians from their home, from work or while traveling, potentially meaning fewer clinic visits.

“The launch of CareLink is a major milestone in the management of heart conditions, and represents an important advance in the ongoing care of patients with implantable devices,” said Dr. John Morgan, professor of cardiology, Southampton University, Southampton, UK. “Patients living with ICDs have reported that frequent clinician visits have a negative impact on their ability to hold down a job, go on holiday, and even spend time with their family. The facilitation of a remote service will free up vital time to improve the patient’s quality of life, and provide more choice and flexibility for patients. It will also offer the peace of mind that comes from knowing that expert care is only a phone call away.”

The Medtronic CareLink Network is also of benefit to physicians. By enabling routine device follow-ups remotely, doctors can quickly and thoroughly review the status of a patient’s heart condition, and schedule follow-up appointments only when necessary. This creates vital extra time to counsel patients with more critical conditions, ensuring medical efficiency and better overall patient management. The Medtronic CareLink Network may also provide reduced emergency department and unscheduled clinic visits. Further, the Medtronic CareLink Network is the first and only system to allow remote monitoring and alerting of fluid buildup in the thoracic cavity, via the proprietary Medtronic OptiVol® Fluid Status Monitoring feature available on select ICDs, potentially preventing heart failure hospitalizations.

“This innovative technology allows us to extend the reach of cardiovascular patient care beyond the clinic walls, and opens up a new way for physicians to treat patients, with the potential for more efficient chronic disease management and better patient outcomes,” said Peter Steinmann, vice president Western Europe for the Cardiac Rhythm Disease Management business at Medtronic. “In addition, the Medtronic CareLink Network is a tremendous convenience for patients and clinicians, and allows patients more security and peace of mind about their devices. The launch of the Medtronic CareLink Network is a truly groundbreaking combination of medicine and technology.”

1 Priori S et al. Task Force on Sudden Cardiac Death, European Society of Cardiology, Summary of recommendations. Europace (2006) 4, 3-18.
2 Medtronic data on file, Jan 2007 (statistics as indicated in the guidelines from the European Society of Cardiology)
3 DP Zipes, D Roberts, for the Pacemaker-Cardioverter-Defibrillator investigators. Results of the International Study of the Implantable Pacemaker Cardioverter-Defibrillator: A Comparison of Epicardial and Endocardial Lead Systems. Circulation. 1995;92:59-65

Medtronic Statement Regarding U.S. Supreme Court’s Granting of Certiorari in Riegel Case

The United States Supreme Court today granted review in Riegel v. Medtronic (NYSE:MDT), a case in which a U.S. Food and Drug Administration- (FDA) approved balloon catheter was used contrary to labeling instructions by the patient's physician. The decision to take up the case means that for the first time, the Supreme Court will decide whether a patient is precluded from seeking state court remedies against the manufacturer of a device approved by the FDA through its rigorous Pre-Market Approval (PMA) process.

In the Riegel case, an Evergreen balloon catheter – no longer manufactured by Medtronic – was inflated by the patient's physician beyond the labeling restrictions and used in a patient for whom it was contraindicated. The trial court in Albany, N.Y., dismissed the suit, finding that the patient was not entitled to state law remedies in light of the prior FDA approval of the device. The Second Circuit Court of Appeals upheld that decision.

All but one of the seven federal circuit courts that have addressed the question of medical device preemption of PMA devices has upheld the doctrine.

In briefing to the Supreme Court on the Riegel case, the FDA and the Solicitor General of the United States argued that the Second Circuit decision in Riegel was correct, the same position argued by Medtronic.

The Supreme Court will hear the case in the term beginning October 2007.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Biosense Webster and Medtronic Form Strategic Alliance to Advance Care for Patients with Cardiac Arrhythmias

Biosense Webster, Inc. the world leader in cardiac mapping and ablation, and Medtronic, Inc. (NYSE:MDT), the world leader in implanted cardiac rhythm devices, today announced plans to collaborate on a clinical trial, educational initiatives and a product development program, all of which are aimed at advancing the care of patients with cardiac arrhythmias, also known as irregular heartbeats.

The initiative was announced today to coincide with the start of Heart Rhythm 2007, the Heart Rhythm Society’s 28th Annual Scientific Sessions, taking place in Denver May 9-12. Heart Rhythm 2007 is the premier medical and scientific conference for electrophysiologists.

“We are pleased to collaborate with Medtronic in this important endeavor,” said Roy Tanaka, President, Biosense Webster, Inc. “This new strategic alliance will leverage the unique resources and technologies of the two companies together, and will benefit the millions of patients who suffer from cardiac arrhythmias around the world.”

Under the terms of the agreement, the two companies plan to collaborate on three key areas of interest – a clinical trial, a technology development initiative and educational programs. The companies intend to design the clinical trial to create a new care pathway for identifying candidates most likely to have a successful ablation treatment outcome and increase the acceptance of ablation therapy.

“Medtronic is intently focused on researching and exploring ways to utilize existing or new technologies for electrophysiologists to better identify and treat patients with cardiac arrhythmias,” said Steve Mahle, President of Medtronic’s Cardiac Rhythm Disease Management business. “This collaboration will begin by bringing the unique competencies of imaging and navigation together with diagnostics and monitoring in an effort to improve the electrophysiologist’s capability in identifying and treating patients. We look forward to collaborating with Biosense Webster to deliver exciting results for our customers.”

In addition, the two companies will work together to advance patient care through a joint research and development program. The companies plan to integrate specific technologies to provide novel, new solutions for the treatment of complex cardiac arrhythmias.

Lifetime education of physicians is a hallmark of both Biosense Webster and Medtronic. Through this relationship, the companies will collaborate to combine resources to extend existing educational opportunities as well as create new instructional programs for electrophysiologists and allied health professionals who work in the arrhythmias field.

“With Biosense Webster, we can continue our commitment to education of physicians at all stages of their career,” said Mahle. “The field of electrophysiology is always changing and advancing and it is vital that physicians and other health care professionals who work in this field are up-to-date on the latest technologies designed to help patients.”

About Medtronic
Medtronic, Inc. (www.medtronic.com ), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

About Biosense Webster
Biosense Webster Inc, a Johnson & Johnson Company, (www.biosensewebster.com ) pioneered EP diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic, and mapping tools. As the leader in navigation systems, Biosense Webster’s technology includes the largest installed base of navigation systems worldwide in leading hospitals and teaching institutions. With proprietary products such as the Carto® XP System, the CartoSound™ Image Integration Software Module, the ThermoCool® Irrigated Tip Catheter and the Lasso® Circular Variable Mapping Catheter, the company is changing the way electrophysiologists diagnose and treat arrhythmias.

New Medical Device and Irrigation Solution Exhibits Promising Results in the Removal of Bacterial Colonization in Chronic Sinus and Ear Infections

Results of a laboratory study presented on Thursday, April 26 at the spring meeting of the American Rhinologic Society (ARS) suggest that pressurized irrigation of the sinuses in conjunction with a specially designed irrigation solution may offer new options to reduce bacteria associated with chronic rhinosinusitis (CRS).

The study, presented by Martin Desrosiers, M.D., associate clinical professor in the Department of Otolaryngology and Allergy at Montreal General Hospital, McGill University in Montreal, Canada, showed a large reduction of very robust and highly adherent bacterial colonies in a laboratory model. Two strains of bacteria, pseudomonas aeruginosa and staphylococcus aureus, were clinically isolated from CRS patients who had poor outcomes following functional endoscopic sinus surgery (FESS). Authors of the study also received the ARS Basic Science Research Award, which was presented to them at the ARS conference.

The bacterial strains were grown into robust bacterial colonies and treated with a variety of commonly used therapies including antibiotics and hypertonic saline. These existing therapies were compared to static and pressurized application of a new irrigation solution under development at Medtronic. Of the S aureus and pseudomonas bacterial colonies grown in this model, respectively 99.98% and 99.999% of the bacteria were removed by the pressurized application.

Traditional Treatment, Emerging Theories and Product Development
Established theory among Ear, Nose, and Throat (ENT) surgeons is that CRS and chronic otitis media with effusion (COME) are inflammatory disorders. Traditional treatments include surgery to ventilate affected areas in an attempt to reduce or eliminate inflammation. However, recent research suggests that CRS and COME are actually chronic infections1, and that the chronic inflammation which accompanies them is a byproduct of the diseases rather than the underlying cause. Specifically, certain strains of bacteria are highly resistant to host defenses and antibiotic treatment, and, as the bacterial colonies persist, they produce toxins that cause chronic inflammation. Based on this mechanism, Medtronic began developing new treatment options for the disruption and removal of bacterial colonies.

Mechanical disruption is one of the best mechanisms for removal of bacterial colonies, and the effect is often enhanced with a detergent. A common example would be brushing one’s teeth. Cavities in the teeth are caused by bacterial colonies in the mouth. Thoroughly brushing the teeth with toothpaste serves to remove the bacterial colonies and prevent decay.

Special irrigation devices for ENT under development by Medtronic adopt a similar approach for the treatment of CRS and COME. Patent applications have been filed on a system that irrigates the nose with pressure, analogous to that used in the dentist’s office or in the treatment of chronic orthopedic wounds. To assist in the treatment, Medtronic scientists developed and evaluated a large variety of irrigating solutions. A citric acid zwitterionic surfactant provided the best results during internal testing. A patent application has been filed on the surfactant also.

Study Results Suggest Improved Efficacy in Bacterial Removal
Researchers at McGill University in Montreal, Montana State and Medtronic collaborated to test the effectiveness of pressurized irrigation with the citric acid zwitterionic surfactant irrigating solution.

Bacteria isolated from failed surgical patients at McGill were sent to Montana State, grown into robust bacterial colonies, and treated with a number of static and dynamic irrigation solutions. Commonly used controls were compared to static and pressurized applications of the Medtronic surfactant. Control groups included many of the currently used irrigation solutions, including antibiotics (tobramycin and doxycycline), and salt water (isotonic and hypertonic saline).

When applied statically, none of the controls had any material effect on the bacterial colony. Conversely, dynamic application of saline reduced the number of bacteria 99.4% in both types of bacterial colonies. Static application of the surfactant reduced the number of bacteria in the colonies of S aureus and pseudomonas 99.66% and 99.87% respectively. The best results were achieved when surfactant was applied under pressure, where 99.98% and 99.999% of S aureus and pseudomonas were removed equaling a four- (10,000x) and five- (100,000x) log reduction, respectively.

Looking Forward
Given the positive results of the laboratory study, Medtronic is initiating a number of studies to further evaluate this technology. Several living tissue and safety studies are scheduled to start in the near future with subsequent submission for review by the FDA.

Additional information about Medtronic’s ENT product line can be accessed on the web at www.MedtronicENT.com

Medtronic to Acquire Breakaway Imaging, LLC

Medtronic, Inc. (NYSE: MDT) announced today it has exercised its option to acquire the O-arm® Imaging System assets of Massachusetts-based Breakaway Imaging, LLC. The acquisition brings the O-arm Imaging System into a broad portfolio of image guided surgical solutions within the Navigation business at Medtronic.

The financial terms of the agreement, which is expected to close in June, are not being disclosed.

“The O-arm represents an important step forward in image-guided surgery for Medtronic’s customers and their patients,” said Jim Cloar, vice president and general manager of the Navigation business at Medtronic. “It will be an essential component in expanding the adoption of minimally invasive spine surgeries and opens the possibility for novel therapies which we believe are the wave of the future.”

The O-arm Imaging System, with a breakable gantry and flat screen detector, provides multi-dimensional surgical imaging. It provides surgeons with 3-D images, as well as multi-plane 2-D, and fluoroscopic imaging. It is intended for use in spinal and orthopedic surgical procedures and is in use in more than 20 locations worldwide. The O-arm Imaging System received FDA clearance in 2005.

About the Medtronic’s Navigation Business
Medtronic Navigation is the world leader in intraoperative Computer Assisted Surgery technologies with its full line of StealthStation® systems. StealthStation combines MRI, CT, or fluoroscopy with optical or proprietary AxiEM™ electromagnetic tracking systems to provide real-time visualization of surgical instruments overlaid on a computer-generated rendition of the patient. Medtronic Navigation has more than 2,000 systems installed worldwide to serve a wide range of medical disciplines including, cranial, spinal, orthopedic and ENT surgical applications.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic Commences Large-Scale Clinical Trial to Evaluate Effectiveness of CRT-D in Japanese Patients

Medtronic (NYSE:MDT) today announced the start of its MOMIJI (Miracle-ICD Outcome Measured In Japanese Indication) clinical trial; the first large-scale, post-market study conducted in Japan sponsored by a medical device company. The MOMIJI trial, which is a prospective, multi-center study enrolling up to 250 patients at approximately 25 centers in Japan, will evaluate the effectiveness of cardiac resynchronization therapy-defibrillator (CRT-D) in Japanese patients as compared to patients studied in the MIRACLE-ICD trial. The MIRACLE-ICD study was a randomized, double-blinded, parallel-controlled clinical trial to evaluate the efficacy of CRT-D in heart failure patients in the United States.

This trial is the result of collaboration between Medtronic Japan and three renowned Japanese physicians: two heart failure specialists, Dr. Shin-ichi Momomura, Professor of Jichi Medical University Omiya Medical Center, and Dr. Hiroyuki Tsutsui, Professor of Hokkaido University; and one electrophysiologist (heart rhythm specialist), Dr. Kaoru Sugi, Professor of Toho University Ohashi Medical Center. The first enrollments were by Dr. Momomura and occurred at the Jichi Medical University Omiya Medical Center.

“I am very excited to be part of this post-market study,” said Dr. Shin-ichi Momomura, the principle investigator of the trial. “The use of CRT-D therapy in patients worldwide has produced encouraging outcomes, but we want to learn more about its effectiveness in the Japanese patients.”

Since 1997, Medtronic has supported more than 20 randomized controlled trials evaluating device therapy in more than 8,000 heart failure patients outside of Japan. These trials have confirmed the efficacy of implantable cardioverter-defibrillators (ICDs) and CRT among certain heart failure patients, including the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) and Cardiac Resynchronization in Heart Failure (CARE-HF) studies. However, this is the first trial that will focus on the effectiveness of CRT-D therapy in a Japan-only cohort; as a result, the study may help determine if the results of foreign trials apply to the Japanese population.

“Medtronic is committed to bringing the newest and best therapies to improve people’s lives in Japan,” said Marshall Stanton, M.D, vice president and general manager of the Cardiac Rhythm Disease Management business for Medtronic in Japan. “The best way to do this is by proving the benefits of therapies through scientific clinical trials.”

Eligible devices for this trial include InSync III Marquis™ CRT-D, the number one selling CRT-D device in Japan, and future Medtronic CRT-D devices as they become commercially available. The InSync III Marquis system combines cardiac resynchronization and defibrillation therapies in a single device for the treatment of moderate to severe heart failure in patients who are at risk for sudden cardiac arrest (SCA). The device received reimbursement approval in August 2006 and has been commercially available for six months.

Heart Failure
Heart failure occurs when the heart is unable to pump enough blood to sustain adequate circulation in the body’s tissues. Unlike a heart attack, heart failure is a condition that typically develops slowly, as the heart muscle weakens and needs to work harder to keep blood flowing through the body. When the heart is not pumping properly, even mild activity can cause shortness of breath or difficulty breathing. Cardiac resynchronization therapy is designed to coordinate the contraction of the heart’s two lower chambers and improve the heart’s efficiency to increase blood flow to the body. More than 1.5 million Japanese suffer from heart failure, the only major cardiac condition that continues to grow in prevalence. Heart failure is reaching epidemic proportions and becoming increasingly burdensome on the healthcare system globally.

About Medtronic
Medtronic, Inc. (www.medtronic.com - NYSE: MDT), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.