Chinese heart valve maker Venus Medtech said today it won China FDA approval for its Venus A-valve device, touting it as the 1st transcatheter aortic valve implantation device to win CFDA approval.
The Venus A-valve device offers a less invasive treatment solution for inoperable and high-risk patients, providing a solution to patients in the region that previously was unavailable, the Hangzhou-based company said.
“We have worked hard to get here, and at Venus Medtech, we believe in innovation through solid science. We will continue to help save lives and treat critical cardiovascular diseases at home and abroad. My vision for Venus Medtech goes beyond TAVR, as we aim to become a leader in the structured heart space. Our CE mark study for the Venus Pulmonary valve has already started as of September 2016. Our global trial for the third generation TAVR device, which embodies pre-packaged, retrievable and embolic protection features, will begin around the end of 2017. Its success should help Venus Medtech further strengthen our position in the market, and gain traction on a more global scale,” Venus Medtech CEO Eric Zi said in a press release.
Venus Medtech said that the Venus A-valve was 1st successfully implanted in Fuwai Hospital on Sept. 10th, 2012.
A study of 101 operative cases of the device reported a successful implantation success rate of 95% and a 30-day all-cause mortality of 5%.
“Venus-A valve’s anti-calcification technology represents a significant development in the application of biological materials in the cardiovascular space, it greatly enhances the valve’s durability, prolongs the valve’s working life, and significantly improves the patient’s experience,” Xingdong Zhang of the National engineering Research Center for Biomaterials said in a prepared release.
“We really value the experience and professionalism of the team under the leadership of Mr. Eric Zi. With the launch of Venus A, we believe Venus Medtech will become a leading cardiovascular company in China, and will also open the door to compete in international markets,” Qiming Venture Partners managing partner Ms. Nisa Leung said in prepared remarks.
Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device.