Privately-held Keystone Heart sells TriGuard embolic protection devices that are designed to protect the brain during transcatheter aortic valve replacement and other cardiac procedures.
Hoping for FDA approval in the third quarter of 2019, Keystone Heart is enrolling patients in the U.S. for a trial of its TriGuard 3 product. The company expects to win CE Mark approval for the device by the end of the first quarter in 2019.
“It is of utmost importance to us that our devices improve the quality life of the patients whom receive them,” Venus Medtech co-founder & CTO Eric Zi said in prepared remarks.
“Our transcatheter heart valve systems offer patients life-saving support – acquiring Keystone Heart allows us the opportunity not only to reduce the risk of brain injury during cardiac procedures but establishes our presence in the US and Europe through which we can introduce our entire portfolio of products. We will be the first to bring the significant and extensive benefits of combining embolic protection devices together with our Venus TAVR products for Chinese’s patients,” Zi added.
“We are excited to be joining a truly entrepreneurial company like Venus,” Keystone Heart’s president & CEO, Chris Richardson, said. “Providing brain protection for every TAVR patient will differentiate Venus Medtech and position them as a leader in structural heart therapies – underscoring its dedication to excellence, determination to provide a total solution for patients undergoing TAVR procedures and focus on patient safety. This partnership provides us the unique opportunity to improve the lives of patients undergoing structural heart procedures with cerebral embolic protection and the ability of bringing new cutting-edge therapies into the US & Europe.”
The companies first announced plans for the merger in September. Also this year, Venus Medtech launched its self-expanding pulmonary valve implant in Canada.