Keystone Heart Ltd. announced that is has received the European CE Mark for its TriGUARD 3, a device designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation and other transcatheter heart procedures.
According to the announcement, the TriGUARD 3 device is now the only product with the CE Mark that is designed to cover and protect all three major cerebral aortic arch vessels. The Nitinol frame and dome-shaped mesh deflector are delivered transfemorally via one of two femoral artery access ports, typically used in transcatheter heart procedures, eliminating the need for a third puncture site. The flexible device “self-positions” in the aortic arch, allowing the device to conform to a variety of patient anatomies.
The Israel-based company recently completed the REFLECT Trial (a pivotal randomized trial of the TriGUARD 3). Keystone Heart is currently finalizing data analysis before applying for FDA approval.
“Taking into consideration the devastating impact of stroke, we are pleased to bring this important technology to patients undergoing any transcatheter heart procedure,” said Chris Richardson, Keystone Heart’s President and CEO, in a statement. “The introduction of the TriGUARD 3 CEP Device in Europe provides physicians the only commercially available device that is designed to protect all three cerebral vessels.”
The device is similar to the ProtEmbo from Protembis, a German firm, that we profiled recently.
Here’s an animation showing how the TriGUARD 3 is used:
Product page: TriGUARD 3 Cerebral Embolic Protection Device
Via: Keystone Heart