Embolic Protection Device Minimizes Cerebral Damage Risk

A new cerebral embolic protection (CEP) device deflects debris away from the brain during transcatheter heart procedures.

The Keystone Heart (Caesarea, Israel) TriGuard 3 CEP is a self-positioning, self-stabilizing device designed to protect all three major arteries that supply blood to the brain to minimize risk of cerebral damage during transcatheter aortic valve replacement (TAVR) and other procedures. The device is shaped to accommodate anatomic variations of the aortic arch, and is designed to deploy rapidly and self-position through a small 8F catheter, providing stable, atraumatic protection and simple retrieval upon completion of the procedure.

Formed to withstand potential interface with the TAVR delivery system and other procedure related accessories, TriGuard 3 is composed of a Nitinol frame and a dome-shaped polymeric mesh deflector--with a pore size of 115 x 145 µm--that is at the same flexible and atraumatic, yet robust and sturdy. The CEP device is placed via one of the two femoral artery access ports typically used in TAVR, thereby eliminating the need for a third puncture site.

“Our next generation device, TriGuard 3 incorporates ease-of-use and anatomy independence, while eliminating device and cerebral branch interaction. This is exactly what our investigators have been asking for in a cerebral embolic protection device.” said Chris Richardson, president and CEO of Keystone Heart, LTD. “Taking into consideration the devastating impact of stroke, we are pleased to bring this important technology to patients undergoing any transcatheter heart procedure.”

“We need the right tools to best combat the risk of stroke and neurological damage associated with TAVR and other cardiovascular procedures,” said Professor Jeffrey Moses, MD, director of advanced cardiac therapeutics at St. Francis Heart Center (Roslyn, NY, USA). “Embolic debris resulting from these procedures can have a grave impact on how post-procedure patients function in their daily lives. The new improvements to TriGuard enhance its ability to become the optimal design for cerebral embolic protection.”

New ischemic brain lesions, or “silent” infarcts, occur in more than 90% of TAVR and other endovascular procedures, according to recent research. These ischemic lesions are associated with adverse neurologic and cognitive consequences, as well as dementia, and have also been shown to increase the risk of stroke by two to four times.

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