JenaValve System Receives Extended CE Mark Approval to Treat Aortic Insufficiency

September 16, 2013—JenaValve Technology, Inc. (Wilmington, DE) announced that it has received European CE Mark approval for its transapical transcatheter aortic valve replacement (TAVR) system for the treatment of aortic insufficiency (AI).

The company noted that the JenaValve system is now approved for the entire range of aortic valve disease—from severely calcified to noncalcified. In September 2011, the device received CE Mark approval for the treatment of stenosed and calcified aortic valve diseases. The JenaValve device is now approved for the treatment of high-risk or inoperable patients with severe AI, also known as aortic regurgitation, in which the native aortic valve does not close properly, allowing blood to leak back into the left ventricle of the heart.

According to the company, JenaValve's features for the treatment of AI is attributable to its clip mechanism that allows for “active fixation” on the diseased valve leaflets and requires no calcification of the native valve to be implanted and effective. The JenaValve system is clipped and fixed onto the native valve leaflets in a manner similar to a paper clip.

The JenaValve prosthesis consists of a natural aortic porcine root bioprosthesis fitted with an outer porcine pericardial patch, a so-called skirt, before being sewn onto a nitinol self-expanding stent. The high-quality bioprosthesis is durable, ensuring long-term aortic valve function. The device's “three-feeler element” allows the clinician to accurately position the prosthesis in the anatomically correct position during implantation, thus ensuring precise subcoronary alignment within the patient's native valve.

Additionally, JenaValve implantation is conducted within the beating heart. Hemodynamic flow is maintained, without cardiac arrest, and rapid pacing is not required during the procedure. The low profile of the stent prosthesis ensures open flow to the coronaries after the implantation. The JenaValve is available in three sizes (23, 25, and 27 mm), covering aortic valve annuli from 21 to 27 mm. The JenaValve is retrievable and repositionable, advised the company.

JenaValve Technology, Inc. is a United States corporation with primary operations in Munich, Germany. The company was founded in 2006 by cardiologists and inventors Prof. Hans R. Figulla, MD, and Prof. Markus Ferrari, MD. The company's transapical aortic valve system has CE Mark approval and is currently marketed in Europe and other markets worldwide. The company's transfemoral TAVI system is expected to enter into clinical study in late 2013 and is anticipated to be available for sale in 2014.

In JenaValve's press release, Prof. Hendrik Treede, MD, Director of Minimally Invasive Cardiac Surgery at the University Heart Center Hamburg in Germany commented, “Severe aortic regurgitation is an indication for surgical aortic valve repair or replacement in the majority of patients. Nevertheless there is a need for interventional catheter based aortic valve implantation in patients at high surgical risk or with contraindications for surgery. First-generation devices require substantial oversizing in noncalcified annuli carrying the risk of paravalvular leakage, valve migration, or further annulus dilatation. The JenaValve system has proven safety and efficacy in catheter-based treatment of pure aortic regurgitation in sufficient numbers of patients. The unique clip mechanism fixes the native leaflets to the stent thereby achieving anatomically correct implantation and full coverage of the native annulus without the need for extensive oversizing and without paravalvular leak. Transapical JenaValve implantation has become the treatment of choice for patients with pure or predominant aortic regurgitation at high risk for surgery at the University Heart Center Hamburg.”