Keystone Heart's TriGuard Cerebral Protection Device Receives CE Mark Approval for TAVR

September 9, 2013—Keystone Heart Ltd. (Caesarea, Israel) announced that its TriGuard cerebral protection device has received European CE Mark approval. The device is not yet commercially available in the United States, advised the company.

According to Keystone Heart, the TriGuard device is designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during transcatheter aortic valve replacement (TAVR) and other cardiovascular procedures. The system can be delivered via one of two femoral artery access ports. TriGuard accommodates most anatomical variations of the aortic arch. The device is composed of a nitinol frame and mesh that are flexible, atraumatic, and sturdy.

In the company's press release, Andreas Baumbach, MD, commented, “TriGuard is the most sophisticated cerebral embolic protection device currently available. The device has the potential to become a routine preventive measure in TAVR and other cardiovascular procedures associated with embolic lesions. European approval of the TriGuard device is an important advancement in patient care.” Dr. Baumbach is Consultant Cardiologist at University Hospitals Bristol in the United Kingdom.

The company noted that data presented in May at EuroPCR 2013, the Paris Course on Revascularization, demonstrated a significant reduction of new brain lesion volume during TAVR using the TriGuard cerebral protection device compared with historical data on unprotected TAVR procedures. The maximum total lesion volume was 95% smaller, and the average total lesion volume was 57% smaller. Clinical studies with the TriGuard cerebral protection device for TAVR procedures are currently ongoing in Europe, Canada, and Brazil.