Medtronic Commences Clinical Trial of Innovative Delivery Technology for Heart Failure Patients with Implanted Cardiac Resynchronization Devices

Medtronic Inc. (NYSE: MDT) today announced the first clinical implants in the United States of the Medtronic Attain Ability™ over-the-wire lead (Model 4196), a dual-electrode left ventricular (LV) lead for use in heart failure patients with cardiac resynchronization therapy (CRT) devices. These implantable devices are used to resynchronize the heart’s ventricles to help pump blood more effectively through the body.

Placing a lead in the LV is widely recognized by physicians as the most challenging aspect of implanting CRT devices. Anatomic challenges can make it difficult to access and work within the coronary sinus to place a lead in the desired vein of the LV. The Attain Ability lead is specially designed for optimal tracking over a guide wire, which is intended to allow physicians greater ability to deliver the left heart lead in difficult to access veins.

Once implanted in the LV, two electrodes located at the tip of the lead provide physicians with options to tailor delivery of stimulation for each patient. When approved by the United States Food and Drug Administration, the Attain Ability lead will be the smallest LV lead in the U.S. market.

The clinical trial will involve up to 200 patients at 25 centers in the U.S. and Canada to determine the safety and efficacy of the Attain Ability lead. First implants in the U.S. were conducted by Dr. Brian Ramza, director of Electrophysiology Laboratory Services at the Mid-America Heart Institute, Saint Luke’s Hospital, Kansas City, MO, and principal investigator of the trial. First implants in Canada were conducted by Dr. Derek Exner, associate professor, Libin Cardiovascular Institute of Alberta.

“The technological advancements found in the Attain Ability lead is designed to provide us with improved ways of reaching and appropriately stimulating the left ventricle, and hopefully providing better therapy to heart failure patients with implanted cardiac resynchronization therapy devices,” said Dr. Ramza, principal investigator of the trial.

Commenting on the clinical trial and the first patient to receive the Attain Ability lead in Canada, Dr. Exner said, “our initial experience with this lead has been positive. It provided additional flexibility, allowing placement in a wider range of vein sizes to better target left ventricle lead placement and will potentially result in better patient outcomes.”

About The Attain Ability Lead
The Attain Ability lead features a unique insulation material, licensed by Medtronic from NASA, which enables the addition of the lead’s two electrodes while maintaining a small lead circumference. This material has been evaluated for space applications, high-performance engines and caustic environments; the Attain Ability lead marks the first time this material has been used in a medical device.

About Cardiac Resynchronization Therapy
CRT resynchronizes the contractions of the heart’s ventricles by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently. CRT defibrillators (CRT-D) also incorporate additional lifesaving therapy to quickly terminate an abnormally fast, life-threatening heart rhythm. CRT and CRT-D have become increasingly important therapeutic options for patients with moderate and severe heart failure since Medtronic first began clinical evaluation of its CRT systems in 1997.

About Heart Failure
Heart failure is a chronic and progressive condition that affects more than five million Americans and more than 22 million worldwide. Heart failure occurs when the heart muscle is unable to pump effectively to meet the body’s need for blood and oxygen. In the late stages of heart failure, the heart cannot keep up with the body’s demand for oxygen-rich blood and its ability to pump blood significantly deteriorates, creating a backup of blood flowing into the heart. This extra blood pools in the pulmonary veins and causes fluid to build in the lungs and other tissues. Additionally, 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.