Israel-based medical device company Keystone Heart has reported positive data from its TriGuard Cerebral Embolic Protection device while it was used during transcatheter aortic valve replacement (TAVR).
TriGuard is a cerebral protection device which has been designed to reduce the amount of embolic material that enters blood circulation to the brain during transcatheter heart valve replacement or implantation.
It fully covers all the areas of brain in order to reduce the risk of cerebral damage during TAVR and other cardiovascular procedures.
The device has been shaped to accommodate varying anatomies of the aortic arch.
It uses a Nitinol frame and mesh which is flexible, atraumatic, it is robust and sturdy and helps in the interface of the device with the TAVR delivery system and other procedure related accessories.
The TriGuard Cerebral Protection Device is placed through one of two femoral artery access ports which is generally used in TAVR, hence eliminating the need for a third puncture site.
It can be deployed rapidly and adjusts its position through a small 9F catheter which can be removed easily.
The device has been designed to offer stable and atraumatic protection.
Keystone Heart conducted a study involving 51 patients undergoing TAVR to test the safety and efficacy of the TriGuard HDH embolic deflection device to protect brain from lesions during TAVR procedures and compared to the existing standard of care.
Results suggested that the patients treated with TriGuard device did not experience strokes, it also recorded a successful device performance without disrupting the TAVR procedure.
Yale School of Medicine and Yale Cardiovascular Research Group Division of Cardiology Alexandra Lansky said: "These data, together with previously reported positive safety, and clinically meaningful outcomes, reinforce the importance of using TriGuard to protect the brain from damage potentially incurred during TAVR procedures.”