March 10, 2020
Keystone Heart's TriGuard 3 Cerebral Embolic Protection Device Receives CE Mark Approval for Use in Transcatheter Heart Procedures
March 10, 2020—Keystone Heart Ltd., a Venus Medtech Company, announced European CE Mark approval for the TriGuard 3 cerebral embolic protection device, which is designed to cover and protect all three major cerebral aortic arch vessels during transcatheter aortic valve replacement (TAVR) and other transcatheter heart procedures.
The company noted that the device's nitinol frame and dome-shaped mesh deflector are delivered transfemorally and designed to "self-position" in the aortic arch, allowing the TriGuard 3 to conform to a variety of patient anatomies.
Nicolas Dumonteil, MD, an interventional cardiologist at Clinique Pasteur in Toulouse, France, commented in the company's announcement, "Even with increased operator experience and availability of next-generation TAVR devices, cerebrovascular complications remain at a stable level, but continue to be the most feared and devastating complications during TAVR. Interventional cardiologists are seeking options to avoid cerebral complications for their patients."
In the United States, Keystone Heart advised that it recently completed the REFLECT pivotal randomized trial of the TriGuard 3 device and is currently finalizing data analysis ahead of the planned marketing application to the FDA.