April 27, 2017
Venus Medtech's Venus A-Valve TAVR Device Approved in China
April 28, 2017—Venus Medtech (Hangzhou) Inc. announced that its Venus A-valve transcatheter aortic valve replacement (TAVR) system has been approved by the China Food and Drug Administration (CFDA) for sale in China for the treatment of inoperable and high-risk patients. This is China's first homemade TAVR device and the first CFDA-approved TAVR device.
Professor Gao Ruilin, MD, led the clinical research efforts for the Venus A-valve, which was first successfully implanted in September 2012 at Fuwai Hospital in Beijing, China.
As part of China's 12th National 5-Year Plan for technological growth, the Venus A-valve study included 101 procedures at leading institutions in China. In the study, the implantation success rate was 95%, and 30-day all-cause mortality was 5%. In the full analysis set, the incidence of composite events (all-cause mortality or severe stroke) at 12 months was 7.1%, which is on par with international trial results, stated the company.
In the company's announcement, Prof. Ruilin commented, "The Venus A-valve is better suited for the Chinese population and physiological characteristics, with a higher implant success rate, similar complication rates, and lower 2-year mortality rate compared to earlier generation TAVR products. The approval of the Venus A-valve by the CDFA is a true blessing for Chinese patients, and a breakthrough in the cardiovascular medical device sector given this product has been approved in China earlier than any comparable imported devices. This makes history."
Addressing the device's clinical performance, Prof. Horst Sievert, MD, Director of the Frankfurt Cardiovascular Center in Frankfurt, Germany, stated, "The product design is highly focused on precision, and the results are satisfactory. Overall, based on available data, the Venus A-valve is superior to global competing products, when applied on Chinese patients."
The company advised that its CE Mark study for the Venus pulmonary valve started in September 2016. The global trial for Venus Medtech's third-generation TAVR device, which embodies prepackaged, retrievable, and embolic protection features, will begin approximately at the end of 2017.