FIH Implantation Performed With Colibri and Venus Medtech's Venibri System

October 27, 2016—The joint venture entity (JVE) formed by Colibri Heart Valve LLC and Venus Medtech announced the first successful implantation of the Venibri transcatheter aortic heart valve (THV) system in a patient at the Institute of Cardiology of Corrientes in Corrientes, Argentina.

Develped by the JVE, the next-generation Venibri valve is a self-expanding, preloaded, prepackaged, ready-for-use, transcatheter aortic valve replacement (TAVR) system that incorporates the Colibri heart valve “dry tissue” technology and the Venus Medtech self-expanding heart valve frame and delivery system.

The first implantation of a 29-mm Venibri valve was performed on October 26 in an 82-year-old woman with severe aortic stenosis by Profs. Mao Chen, MD, and Yuan Feng, MD, with the West China Hospital, Sichuan University in Chengdu, Sichuan, China, and Jorge Baccaro, MD, with the Institute of Cardiology of Corrientes in Corrientes, Argentina.

The JVE noted that the valve insertion, advancement, and deployment were smooth and stable. Approximately two-thirds into deployment, blood pressure recovered to a normal range, indicating that the leaflets were immediately functioning. The postdeployment angiogram demonstrated that the Venibri heart valve leaflets functioned immediately. The total time of the procedure was approximately 15 minutes. With success of the first valve, a 26-mm Venibri valve was implanted on October 27 in another patient, an 81-year-old woman with severe aortic stenosis.

In the announcement, Prof. Chen commented, “The Venibri THV system is very easy to use and helpful in saving precious time for patients. It provides the opportunity to treat emergent, severe, and critical aortic stenosis patients easily and effectively.”

Prof. Horst Sievert, MD, added, “Dry tissue technology has become another important milestone since the first-ever TAVR case in 2002. These advantages of the Venibri THV system turned a complex TAVR procedure into a relatively easy one, like a percutaneous coronary intervention procedure. I believe physicians and patients will broadly benefit from this new technology.” Prof. Sievert is Director of the CardioVascular Center Frankfurt in Frankfurt, Germany.

The JVE, through the combination of the Colibri Heart Valve and Venus Medtech technologies, will develop and commercialize both self-expanding and balloon-expandable prepackaged, ready-for-use THV systems in China and emerging Asian markets. Colibri Heart Valve will have the rights to the JVE products for markets in the North America, Europe, Japan, Australia, and New Zealand.