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Evera ICDs get CE Mark for sale in Europe

Posted by: James Walsh Updated: February 5, 2013 - 10:42 AM
Medtronic this week announced European (CE Mark) approval of its Evera implantable cardioverter-defibrillators (ICDs). According to Medtronic, Evera offers increased longevity and “the most advanced shock reduction technology available.”
 
Designed with thin, smooth edges and a contoured shape, Evera ICDs are supposed to increase patient comfort by fitting better inside the body. The device is not approved for sale in the U.S.
 
According to Medtronic, Evera boasts a battery life of up to 11 years. That’s a 25 percent increase in battery longevity, Medtronic said. It is paired with Medtronic’s Quattro Secure lead. A lead is the wire that connects an ICD to the heart. The Quattro Secure is the only lead with 10 years of proven performance with active monitoring, Medtronic said.
 
As younger patients are increasingly fitted with ICDs and pacemakers, device-makers are working to develop technology that is more durable and more able to survive the stresses of active lives. Medtronic says its Evera family of ICDs is a step in that direction.
 
“Evera offers patients and physicians a unique standard in modern ICD treatment," said Dr. Joerg O. Schwab, 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."
 
Shock reduction also has become a focus. ICDs deliver a life-saving jolt to the heart, but it can be a painful punch to the chest when the device inaccurately senses the need to provide therapy. Medtronic says its exclusive SmartShock Technology uses an improved shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms.
 
According to the Fridley med tech company, the device has proven to be 98 percent inappropriate shock-free rate after a year.
 
"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 Dr. Marshall Stanton, vice president and general manager of the tachycardia business at Medtronic.
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