Keystone Heart this week said it won CE mark approval for its TriGuard 3 Cerebral Embolic Protection device.
TriGuard 3 is designed to reduce the risk of cerebral damage by deflecting debris from cerebral circulation during trans catheter aortic valve implantation and other transcatheter heart procedures, according to the company.
“Even with increased operator experience and availability of next-generation TAVI devices, cerebrovascular complications remain at a stable level, but continue to be the most feared and devastating complications during TAVI,” interventional cardiologist based in Toulouse, France Dr. Nicolas Dumonteil said in a news release. “Interventional cardiologists are seeking options to avoid cerebral complications for their patients.”
The device can cover and protect all three major cerebral aortic arch vessels. It features a Nitinol frame and dome-shaped mesh deflector that are delivered transfemorally to self-position in the aortic arch. The design allows for the device to conform to a number of patient anatomies.
“Taking into consideration the devastating impact of stroke, we are pleased to bring this important technology to patients undergoing any transcatheter heart procedure. The introduction of the TriGuard CEP Device in Europe provides physicians the only commercially available device that is designed to protect all three cerebral vessels,” president and CEO Chris Richardson said.