Medtronic’s Newly CE Marked Evera® ICD Claims Enhanced Longevity, Shock Reduction And Patient Comfort

In short

Medtronic’s Evera® portfolio of implantable cardioverter-defibrillators (ICD) has attained CE Mark status. The company is claiming this product represents quite a leap forward, with its increased longevity and the most advanced shock reduction technology available. In addition Evera is the first ICD family to feature the PhysioCurve® design, a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by a reported 30 percent.

Background

Medtronic says its Evera system delivers up to a 25 percent increase in battery longevity (up to 11 years) compared to previous devices. In addition, Evera also is paired with the reliable Sprint Quattro® Secure lead, the only ICD lead with 10 years of proven performance with active monitoring.

The Evera system includes SmartShock™ 2.0, the next-generation version of the technology featuring enhanced shock reduction with added performance and simplified programming. 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.

Physician comments

“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.”

Company comments

“Our new, Evera family of ICDs delivers on our strategy to develop a comprehensive system to reduce many common complications that have been part of receiving an ICD; we have introduced a unique shape to enhance patient comfort, incorporated the most advanced shock reduction technology available, developed a longer-lasting battery than its predecessors, while using the most reliable ICD lead (Sprint Quattro) available,” said Marshall Stanton, M.D., vice president and general manager of the tachycardia business at Medtronic. “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. Evera builds upon 20 years of leadership at Medtronic in driving product innovation and advancements in shock reduction therapy and device longevity.”

Regulatory status

The Medtronic Evera ICD is not approved for sale in the United States.

Source: Medtronic, Inc.