JenaValve Technology GmbH, a German medical device company specializing in the development of transcatheter heart valve implantation systems, announced today that the Company has received CE mark approval for its transapical TAVI system of the second-generation. 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.
"After an exciting and suspenseful development period, we are now able to commercially release our TAVI system of the second generation, firstly onto the European market," said Helmut Straubinger, President and CEO of JenaValve Technology. "Our transapical TAVI system is designed to offer patients and teams of cardiac surgeons and cardiologists a significant advantage over currently available transcatheter aortic valve implantation systems."
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 preeminent EACTS scientific meeting on October 3, 2011, in Lisbon.
In his podium presentation, cardiac surgeon Dr. Hendrik Treede 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. Dr. Friedrich-Wilhelm Mohr, 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 Prof. Mohr.