JenaValve Receives CE Mark Approval for Second-Generation TAVI System

September 30, 2011—JenaValve Technology GmbH (Munich, Germany) announced that the company has received CE Mark approval for its second-generation transapical transcatheter aortic valve implantation (TAVI) system for the treatment of severe aortic valve stenosis in elderly high-risk patients, especially in patients for whom surgery is not an option.

The company stated the transapical TAVI system consists of both the catheter delivery system and the JenaValve heart valve prosthesis. The system is available in three sizes and covers aortic annulus diameters from 21 to 27 mm. The JenaValve prosthesis features a low profile, positioning feelers, the JenaClip anchoring mechanism, and the ability to reposition the prosthesis.

According to JenaValve Technology, the pivotal study in support of the CE Mark approval is a prospective, multicenter, uncontrolled clinical trial composed of 73 patients with severe symptomatic aortic valve stenosis at seven German study sites between October 2010 and July 2011. The trial's primary endpoint was the 30-day mortality rate. The secondary endpoints were the rate of successful implantation and further parameters for performance and safety of the prosthetic heart valve.

On October 3, 2011, Hendrik Treede, MD, presented the first results of the study's primary endpoint at the EACTS (European Association for Cardiothoracic Surgery) annual scientific meeting in Lisbon, Portugal.

The study's Principal Investigator, Prof. Friedrich-Wilhelm Mohr, MD, commented, “The study appears to be progressing very promisingly, and the 30-day trial data support the safety and efficacy of the JenaValve system. Now patients have access to a new-generation system for transapical TAVI treatment. The JenaValve design allows the cardiac surgeon and cardiologist to achieve precise positioning and allows repositioning of the heart valve prosthesis with its unique, patented positioning feelers. It is with these key features that the system distinguishes itself from its competitors.”