JenaValve Reports on TAVI Trial With 27-mm Transapical Prosthesis

January 18, 2011—JenaValve Technology, Inc. (Munich, Germany) announced the successful transcatheter aortic valve implantation (TAVI) of a 27-mm transapical aortic valve prosthesis. Hendrik Treede, MD, performed the procedure on a patient included in JenaValve's ongoing pivotal CE Mark trial.

The company noted that CE Mark approved transapical TAVI products currently available on the market are indicated for annular sizes up to 25 mm, so that more than 30% of all patients with symptomatic severe aortic stenosis are not referred or are contraindicated from current surgical valve replacement. JenaValve's 27-mm device is designed to expand the eligible patient population.

The company announced the initiation of the trial in November 2010, as reported by Cardiac Interventions Today. JenaValve's multicenter CE Mark pivotal study is evaluating the safety and effectiveness of its transapical TAVI system. The primary endpoint of the trial is the 30-day mortality rate with secondary endpoints of procedural success, valve performance, and safety.

“The procedure was very straightforward and uneventful,” commented Dr. 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.”

The company stated that its transapical platform is designed for use by heart surgeons, and it is developing a transfemoral platform for cardiologists. The systems are composed of a catheter delivery system, a self-expanding nitinol stent, and a heart valve. The transapical prosthesis uses a porcine root valve. The transfemoral prosthesis is a pericardial tissue construct, allowing for a small catheter diameter. JenaValve expects to launch it transapical TAVI system in Europe in 2011.