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