JenaValve Technology has announced that the company has received CE mark approval for its transapical transcatheter aortic valve implantation (TAVI) system of the second generation.
“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, multicentre, 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 were presented at the European Association for Cardio-Thoracic Surgery annual meeting in Lisbon. The data were presented by cardiac surgeon Hendrik Treede, University Heart Center, Hamburg, Germany.
Friedrich-Wilhelm Mohr, medical director, Department of Cardiac Surgery at the University of Leipzig Heart Center, is the principal investigator of the multicentre 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 27mm.