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.