Medtronic Receives CE Mark for ICD Portfolio

Minneapolis, Minn.-based medical device company Medtronic Inc. has been granted the CE mark for the Evera portfolio of implantable cardioverter defibrillators (ICDs). According to Medtronic, the family of devices has increased longevity and advanced shock reduction technology. The ICDs feature a contoured shape with thin, smooth edges, a shape that is patented by Medtronic under the name PhysioCurve. The shape is designed to reduce skin pressure by 30 percent. CE mark gives the green light for the devices to be marketed in the European Union. The Evera line is not approved in the United States.

The company claims the Evera devices’ battery longevity has been increased by 25 percent compared to previous devices. This translates to approximately 11 years. The ICDs are paired with Sprint Quattro Secure leads, which have been on the market for a decade.

“Evera offers patients and physicians a unique standard in modern ICD treatment,” said Prof. Joerg O. Schwab, M.D., FESC, FHRS, professor of cardiology at the University Hospital of Bonn, in Bonn, Germany. “With a new shape designed for comfort, greater longevity, the most advanced shock reduction capabilities available on the market, and a best-in-class lead with 10 years of proven reliability, this advanced comprehensive ICD technology works to improve patients’ overall quality of life.”

Evera devices also have Medtronic’s SmartShock technology, which enables the device to better differentiate between dangerous and harmless heart rhythms, and delivers a reported 98 percent inappropriate shock free rate at one year. SmartShock 2.0, the newest version of this technology, adds simpler programming to its offerings. Also included in the new ICD portfolio is OptiVol 2.0 fluid status monitoring and complete diagnostics, which helps to identify patients at risk of worsening heart failure and atrial fibrillation.

“Patients suffering from debilitating heart rhythm disorders can rely on new treatment options that can significantly improve their quality of life, while adding peace of mind,” said Marshall Stanton, M.D., vice president and general manager of the tachycardia business at Medtronic.

Numerous studies have found that ICDs improve survival when patients meet evidence-based guidelines. In a recently published analysis in the Journal of the American Medical Association, survival among real-world ICD patients receiving ICDs for primary prevention was similar to patients in two major clinical trials.