CE Mark Study Begins for Transapical TAVI System


November 3, 2010

November 3, 2010 – A multicenter CE-mark study has been launched for transapical TAVI system. Hendrik Treede, M.D., performed the first implantations of the system, made by JenaValve, at the Universitäres Herzzentrum Hamburg.

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.

Its design enables physicians to advance, rotate, reposition or retract the feelers as necessary, leading to correct and precise placement of the prosthesis.

“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," said Friedrich-Wilhelm Mohr, M.D., Ph.D., director of the clinic for cardiac surgery, Heart Center Leipzig and principal investigator of the study.

The company anticipates completion of patient enrollment in the first quarter of 2011 and CE-mark approval in the third quarter of 2011.

For more information: www.jenavalve.de