CE Mark for Keystone Heart’s TriGuard™ Cerebral Protection Device

Israeli company Keystone Heart, a developer of cerebral protection devices for interventional cardiology and cardiac surgery procedures, has announced the CE marking of its TriGuard™ Cerebral Protection Device.

Background

Preserving cerebral function is a key component to procedural success and patient care when undertaking significant heart surgery.

Cerebral injury concurrent with cardiovascular procedures has increased as procedures become more complex and less invasive. This is particularly significant with the introduction of transcatheter aortic valve replacement (TAVR) procedures. Indeed data from one study, the so-called PARTNER A study, showed nearly twice as many strokes in the TAVR group compared with the surgical Aortic Valve Replacement (AVR) group at 30 days. The majority of strokes were peri-procedural and within the first 2 days. The newer, “next generation” TAVR devices have so far have apparently failed to reduce TAVR-related risk of stroke.

In a press release issued on September 9th, Keystone Heart says its TriGuard mesh-based filter is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during TAVR and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports. The TriGuard™ accommodates most anatomical variations of the aortic arch and uses a Nitinol® frame and mesh – flexible and atraumatic, yet robust and sturdy.

New scientific data presented at EuroPCR, demonstrated a significant reduction of new brain lesion volume during TAVR using TriGuard™ Cerebral Protection Device, compared with historical data on unprotected TAVR procedures. The clinical data shows that Maximum Total Lesion Volume was 95% smaller and Average Total Lesion Volume was 57% smaller when compared with historical references.

Physician comments

Dr. Andreas Baumbach, Consultant Cardiologist at University Hospitals Bristol, UK and honorary Reader in Cardiology at the University of Bristol: “TriGuard is the most sophisticated cerebral embolic protection device currently available. The device has the potential to become a routine preventive measure in TAVI and other cardiovascular procedures associated with embolic lesions. European approval of the TriGuard device is an important advancement in patient care.”

The TriGuard Device is not yet commercially available in the USA.

Source: Keystone Heart, PR Newswire