JenaValve Technology, a Germany-based medical device company, has received CE mark approval for its second-generation transapical transcatheter aortic valve implantation (TAVI) system, designed to treat severe aortic valve stenosis in elderly high-risk patients.
The TAVI system incorporates both the Cathlete delivery system and the JenaValve heart valve prosthesis.
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The approval is based on a 73-patient prospective multicentre uncontrolled clinical trial, which supported the safety and efficacy of the JenaValve system.
The primary endpoint of the trial was the 30-day mortality rate, while the secondary endpoints included the rate of successful implantation, as well as further parameters for performance and safety of the prosthetic heart valve.
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