JenaValve, a German developer of transcatheter-delivered aortic valve systems, has received CE marking for its transapical trans-aortic valve implantation (TAVI) system comprised of the Cathlete delivery system and the JenaValve prosthetic heart valve (pictured). The transapical JenaValve prosthesis includes a porcine root valve and a Nitinol stent designed to improve hemodynamic performance and durability. The prosthesis comes in three sizes and covers aortic annulus diameters of 21-27mm.
The system is indicated for the treatment of aortic stenosis in older, high-risk patients who are ineligible for open heart surgery. CE marking was awarded following successful outcomes from a pivotal multi-center German study of 73 patients with severe symptomatic aortic valve stenosis.
From the press release:
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.
Product page: JenaValve…