JenaValve™ Technology, Inc., a medical device company specialized in developing transcatheter valve replacement products, announced today the start of its multicenter CE-mark study. The first two implantations of its transapical TAVI system were performed by Dr. med. Hendrik Treede at the Universitäres Herzzentrum Hamburg.
“European and US cardiac surgeons and cardiologists are following JenaValve with interest and have referred many elderly patients whom we have qualified. The study is important because, if approved, it may identify a new transapical TAVI system generation which promises precise implantation and ease-of-handling for physicians.”
At the end of September 2010 JenaValve received approval from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) to conduct a multicentric pivotal study to evaluate the safety and effectiveness of its transapical TAVI system. 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; secondary endpoints are procedural success, valve performance and safety.
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.
Prof. Dr. med. Friedrich-Wilhelm Mohr, Director of the Clinic for Cardiac Surgery, Heart Center Leipzig and Principal Investigator will lead the multicenter CE-mark study. According to Prof. Mohr, “European and US cardiac surgeons and cardiologists are following JenaValve with interest and have referred many elderly patients whom we have qualified. The study is important because, if approved, it may identify a new transapical TAVI system generation which promises precise implantation and ease-of-handling for physicians.”
Helmut J. Straubinger, CEO of JenaValve Technology, commented, “In the weeks ahead our resources will converge to ensure the support and success of the transapical CE-mark study. The development of our transfemoral TAVI system continues in parallel.” The company anticipates completion of patient enrollment in Q1 2011 and CE-mark approval in Q3 2011.
JenaValve completed patient enrollment of the First-in-Man study in April 2010. Initial results of the 30-day mortality as primary endpoint were presented at the TCT in Washington, D.C.
SOURCE JenaValve Technology