News | January 31, 2011

First 27 mm Transcatheter Aortic Valve Deployed

January 31, 2011 – The first successful transcatheter implantation of a 27 mm transapical aortic valve prosthesis has been completed. The procedure was performed by Hendrik Treede, M.D., at the University Heart Center Hamburg using JenaValve’s transcatheter aortic valve implantation (TAVI) system.

It was part of the company’s ongoing pivotal CE mark trial

"The procedure was very straightforward and uneventful," said Treede. "Our experience with the JenaValve system is that it provides a stable platform for cardiac surgeons to carefully position and release the prosthesis. JenaValve's technology represents a noteworthy clinical and technical achievement allowing us to expand the use of life-enhancing TAVI procedures."

Current CE-certified transapical TAVI products are indicated for annular sizes up to 25 mm. With the availability of a transapical aortic prosthesis for sizes up to 27mm, the market for TAVI patients will be significantly expanded, providing life-saving therapy to patients previously left untreated. According to Helmut J. Straubinger, CEO of JenaValve, more than 30 percent of all patients with symptomatic severe aortic stenosis (SAS) are not referred or are contraindicated from current surgical valve replacement.

The company is in the midst of a multicenter CE-mark pivotal study to evaluate the safety and effectiveness of its transapical TAVI system. The primary endpoint of the trial is the 30-day mortality rate. Secondary endpoints are procedural success, valve performance and safety.

JenaValve expects to enter the European market with its transapical TAVI system in 2011.

Aortic stenosis, the most prevalent heart valve disease in Western countries, is increasing steadily with an aging population. The decision to surgically replace a diseased aortic valve is problematic in elderly patients due to associated high mortality and morbidity risks. In fact, elderly patients with severe aortic disease symptoms are not often considered candidates for surgery.

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