Israel-based medical device firm Keystone Heart has entered into a partnership agreement with China-based heart valve developer Venus Medtech (Hangzhou) to offer cerebral embolic protection with transcatheter heart valve systems in select Asian markets such as China.
Under the agreement, the firms will provide Keystone Heart's cerebral embolic protection device TriGuard in combination with Venus Medtech's Transcatheter Aortic Valve Replacement (TAVR) system.
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The CE marked TriGuard is designed to offer full coverage to all brain territories to decrease the risk of cerebral damage during cardiovascular procedures such as TAVR.
The shape of the device accommodates the aortic arch's anatomic variations, while its Nitinol frame and mesh enables the device to withstand potential interface with the TAVR delivery system.
Venus Medtech president and chief executive officer Eric Zi said: "Our transcatheter heart valve systems offer patients life-saving support, and collaborating with Keystone Heart allows us the opportunity to reduce the risk of brain injury during the procedure.
"No other company offers this combination."
TAVR is a minimally invasive surgical procedure to repair a damaged aortic valve.
Venus Medtech's transcatheter pulmonic valves are currently undergoing clinical trials and are yet to be approved by China Food and Drug Administration (CFDA).
The TriGuard eliminates the need for a third puncture site during TAVR, as it can placed through one of two femoral artery access ports used.
It is claimed to deploy rapidly and self-position through a small 9F catheter.
Venus Medtech focuses on developing heart valves for increased safety and long term durability, while Keystone Heart aims at protecting the brain from emboli to minimise the risk of brain infarcts during cardiovascular procedures.
