TAVI: Medtronic lands European win for next-gen Engager heart valve

February 28, 2013 by Arezu Sarvestani

Medtronic lands CE Mark approval in the European Union for its new Engager transcatheter aortic valve implantation system.

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Medical device giant Medtronic (NYSE:MDT) won European regulatory approval for its Engager transcatheter aortic valve implantation system, the company announced today.

The CE Mark indication includes approval for transapical delivery of the valve in treatment of patients with aortic stenosis who are too sick to undergo traditional surgery.

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The Engager system boasts some upgrades over the company's flagship CoreValve TAVI system, including features that help reduce paravalvular leakage, one of the chief concerns about TAVI technology.

The Engager technology also demonstrated a more level learning curve, with successful device deployment in 94.3% of procedures in the European Pivotal Trial, according to a press release.

"The Engager valve has demonstrated exceptional clinical results, and by adding it to our transcatheter valve portfolio, we are providing heart teams with more options for achieving the best outcomes for every patient with severe aortic stenosis," Medtronic structural heart business senior vice president Dr. John Liddicoat said in prepared remarks.