The World 1st Successful Human Implantation of Aortic Valve
The joint venture entity (JVE) from Colibri Heart Valve and Venus Medtech achieve a significant milestone by advancing a next generation, disruptive, pre-packaged, ready-for-use, self-expanding transcatheter aortic heart valve.
CORRIENTES, Argentina and HANGZHOU, China, Oct. 27, 2016 /PRNewswire/ -- The joint venture entity (JVE), created by Colibri Heart Valve and Venus Medtech announce today the successful implantation of the Venibri Valve, a self-expanding, pre-packaged, ready-for-use, transcatheter aortic heart valve system in a patient at the Institute of Cardiology of Corrientes in Argentina on October 26. The next-generation, disruptive Venibri Valve was developed by the JVE and is a milestone for the treatment of aortic valve stenosis. The Venibri Valve is the world's first self-expanding pre-loaded, pre-packaged, ready-for-use, transcatheter aortic heart valve system, which incorporates the proprietary Colibri Heart Valve "dry tissue" technology and the Venus Medtech self-expanding heart valve frame and delivery system. The Colibri Heart Valve tissue has undergone extensive testing and was recently cleared by the U.S. FDA for use as a soft tissue repair product by Colorado Therapeutics LLC.
The first implantation of the Venibri Valve in a patient was performed by Prof. Mao Chen, Prof. Yuan Feng from the West China Hospital, Sichuan University, China and Dr. Jorge Baccaro from Institute of Cardiology of Corrientes in Argentina on October 26. The 82-year-old female patient suffered from severe aortic stenosis. Upon confirming the appropriate valve size for the patient, a 29mm Venibri Valve system incorporating the pre-crimped, pre-loaded, pre-packaged "dry" heart valve was removed from the package and the guidewire lumen and flush port were injected with saline to purge the system of air. The Venibri Valve delivery system was then inserted into the femoral artery over the guidewire. The valve insertion, advancement, and deployment was smooth and stable. Upon 2/3 deployment, blood pressure recovered to a normal range indicating the leaflets were immediately functioning. The post deployment angiogram demonstrated the Venibri heart valve leaflets functioned immediately. Total time from opening the ready-for-use Venibri THV system to valve deployment was approximately 15 minutes. With success of the first valve, on October 27, a 26mm Venibri Valve was implanted in another patient, an 81-year-old female patient with severe aortic stenosis. Total implantation from opening the package took approximately 16 minutes.
The Successful Worldwide First in Human Implantation of the Innovative heart valve -- Venibri
The operators were quite impressed with the clinical performance of the Venibri Valve. 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, director of the CardioVascular Center Frankfurt, highly praised the technology, "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 PCI procedure. I believe physicians and patients will broadly benefit from this new technology."
"The advancement of the Venibri THV system is further validation for the Colibri "dry" tissue technology and compliments the previous FIH experience demonstrated with the Colibri pre-packaged, ready-for-use, balloon expandable THV system," stated Dr. R. David Fishone of the co-founders of Colibri Heart Valve. Dr. David Paniagua, co-founder of Colibri Heart Valve also stated, "This successful first-in-human implantation of the Venibri THV system is a significant milestone demonstrating the value of the Colibri "dry" tissue technology and will be a meaningful advancement for the treatment of severe aortic valve stenosis."
"The JVE will offer both a self-expanding and balloon-expandable pre-packaged, ready-for-use, THV system to address the large and growing aortic stenosis in the Chinese and emerging Asian markets." Stated Eric Zi, president and CEO of Venus Medtech Hangzhou. "The convenience and benefits offered by the Venibri Valve will allow the JVE to successfully penetrate the significant aortic stenosis market in China and emerging Asian markets."
The JVE, through the combination of the Colibri Heart Valve and Venus Medtech technologies, will develop and commercialize both self-expanding and balloon-expandable pre-packaged, ready-for-use transcatheter heart valve (THV) systems in China and emerging Asian markets. Colibri Heart Valve will have the rights to the JVE products for the North American, European, Japanese, Australian, and New Zealand markets.
"The recent successful first-in-human implantation of the Venibri Valve system is a testament to the technology benefits formed by the combination of the Colibri and Venus technologies," stated Joseph B. Horn, president and CEO of Colibri Heart Valve. "We look forward to further clinical and commercial advancement of the Colibri and Venus Medtech technologies through the JVE to provide a breakthrough in advancement of patient treatment of severe aortic stenosis."