JenaValve Technology, a medical device company specialised in developing transcatheter valve replacement products, has initiated its multicenter CE-mark study to evaluate the safety and effectiveness of its transapical transcatheter aortic valve implantation (TAVI) system.
The JenaValve transapical TAVI system is designed for the treatment of severe stenotic aortic valve disease in elderly high-risk patients, especially those unsuitable for conventional open heart surgery.
Reportedly, at the end of September 2010, JenaValve has received approval from the Federal Institute for Drugs and Medical Devices, to conduct a multicentric pivotal study.
The CE-mark trial is designed as a prospective multicentric uncontrolled study in which up to 70 patients with severe symptomatic aortic valve stenosis will be enrolled.
The primary endpoint of the trial is a 30-day mortality rate and secondary endpoints are procedural success, valve performance and safety.
JenaValve Technology CEO Helmut Straubinger said that in the weeks ahead their resources will converge to ensure the support and success of the transapical CE-mark study and the development of transfemoral TAVI system continues in parallel.