JenaValve Initiates Study for Its Transapical TAVI System in Europe

November 2, 2010—JenaValve Technology, Inc. (Munich, Germany) announced the start of a multicenter European study of its transapical transcatheter aortic valve implantation (TAVI) system.

In September 2010, the company received approval from Germany's Federal Institute for Drugs and Medical Devices to conduct a multicenter pivotal study to evaluate the safety and effectiveness of its transapical TAVI system. The CE Mark trial is designed as a prospective, multicenter, uncontrolled study that will enroll up to 70 patients with severe symptomatic aortic valve stenosis.

The primary endpoint of the trial is a 30-day mortality rate; secondary endpoints are procedural success, valve performance, and safety. Professor Friedrich-Wilhelm Mohr, MD, is the study's principal investigator. Hendrik Treede, MD, performed the study's first two implantations of the device at the Universitäres Herzzentrum Hamburg. The company anticipates completion of patient enrollment in the first quarter of 2011 and CE Mark approval in the third quarter of 2011.

JenaValve completed patient enrollment of the first-in-man study in April 2010. Initial results of the 30-day mortality rate as a primary endpoint were presented in September at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC, and published in the meeting's supplement to the Journal of the American College of Cardiology (2010;56:B77–B78).

According to the company, the JenaValve transapical TAVI system is designed for the treatment of severe stenotic aortic valve disease in elderly high-risk patients, especially those who are unsuitable for conventional open heart surgery. The device features a low-profile prosthesis and stent design, feeler-guided positioning, the company's JenaClip anchoring mechanism, the ability to reposition and retrieve the device, and enhanced radiopacity.