JenaValve First to Receive CE Mark for Second-Generation Transapical TAVI System


October 3, 2011

October 3, 2011 — JenaValve Technology GmbH, a German company specializing in the development of transcatheter heart valve implantation (TAVI) systems, received CE mark approval for its second-generation transapical TAVI. This system is used to treat severe aortic valve stenosis in elderly high-risk patients, especially in patients for whom conventional open-heart surgery is not an option.

The pivotal CE-marking study is a prospective, multicenter, uncontrolled clinical trial comprising 73 patients with severe symptomatic aortic valve stenosis, which was held at seven German study sites between October 2010 and July 2011. The primary endpoint of the trial was the 30-day mortality rate. The secondary endpoints were the rate of successful implantation, as well as further parameters for performance and safety of the prosthetic heart valve. The first results of the study's primary endpoint are being presented at the pre-eminent EACTS scientific meeting on Oct. 3, 2011, in Lisbon.

In his podium presentation, cardiac surgeon Hendrik Treede, M.D., from the University Heart Center in Hamburg will present the study data ("Safety and efficacy outcomes from the multicenter CE-mark study using the JenaValve second-generation transcatheter aortic valve implantation (TAVI) system"). The presentation will take place at 11:45 in Auditorium 1 at the Lisbon Congress Center.

Prof. Friedrich-Wilhelm Mohr, M.D., medical director of the department of cardiac surgery at the University of Leipzig Heart Center, is the principal investigator of the multicenter study. "The study appears to be progressing very promisingly, and the 30-day trial data support the safety and efficacy of the JenaValve system. Now patients have access to a new generation system for transapical TAVI treatment. The JenaValve design allows the cardiac surgeon and cardiologist to achieve precise positioning and allows repositioning of the heart valve prosthesis with its unique, patented positioning feelers. It is with these key features that the system distinguishes itself from its competitors,” said Mohr.

The transapical TAVI system consists of both the Cathlete delivery system and The JenaValve heart valve prosthesis. The product is available in three sizes and covers aortic annulus diameters from 21 to 27 mm.

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