Medtronic lands Euro win for next-gen heart implants

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Medtronic (NYSE:MDT) touted CE Mark approval in the European Union for its next-generation Evera portfolio of implantable cardioverter-defibrillators.

European regulators approved the new family of ICDs, which boasts a battery life of up to 11 years and features a thinner, more contoured designed that may fit better inside the body, the company announced today.

The Evera implants, which are not yet approved for the U.S., also feature "SmartShock 2.0," the new iteration of Medtronic’s shock reduction algorithms that helps the device better distinguish between dangerous and harmless heart rhythms, according to a press release.

"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," Medtronic tachycardia business general manager and vice president Dr. Marshall Stanton said in prepared remarks. "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."

Minneapolis medical device titan Medtronic has notched a series of wins already this year, including expanded CE mark for its neurostimulation implants to cover full-body MRI scanning and new European regulatory indications for its Complete SE self-expanding vascular stent system.

Medtronic has also made progress with U.S. regulatory programs, closing enrollment in the U.S. arm of a study evaluating its IN.PACT Admiral drug-eluting balloon and winning FDA clearance for its next-generation FlexCath Advance steerable sheath for use with the company’s Arctic Front cryoablation system.

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