Keystone Heart announces first commercial case performed worldwide with the TriGUARD 3™ cerebral embolic protection device
Keystone Heart, LTD., a medical device innovator driven to redefine the standard of structural heart care, has announced completion of the first worldwide commercial case using the TriGUARD 3™ Cerebral Embolic Protection (CEP) Device. Pieter Stella, MD, Assistant Professor, Medical Department of Cardiology, at UMC Utrecht in the Netherlands, successfully performed the transcatheter aortic valve implantation (TAVI), utilizing the TriGUARD 3™ device, which is designed to minimize the risk of cerebral damage during trans-catheter heart procedures.
"Although we have seen improvement in mortality and morbidity rates during TAVI procedures, the risk of periprocedural stroke has not changed," commented Professor Stella. "As a physician, I am driven to do anything possible to prevent this rare but terrible complication. I am pleased we can now routinely use the TriGUARD 3™ CEP device in all of our TAVI cases to protect patients from stroke, delirium, and neurocognitive decline."
The TriGUARD 3™ CEP device is the only CE Marked product designed to cover and protect all three major cerebral aortic arch vessels. The state-of-the-art Nitinol frame with dome-shaped mesh deflector is delivered transfemorally and designed to "self-position" in the aortic arch. This design allows the TriGUARD 3™ CEP device to conform to a variety of patient anatomies.
"Our team is thrilled to commercially launch the only CE Marked device designed to cover and protect all three cerebral vessels," stated Chris Richardson, Keystone Heart President and CEO. "Our primary objective is to ensure a controlled launch that provides physicians the training and tools necessary to safely and consistently treat all patients undergoing trans-catheter heart procedures with the TriGUARD 3™ CEP device."
Richardson further commented, "As TAVI procedures continue to expand into treating lower-risk patient groups, the need to protect patients' brains will also grow. Strokes and minor cognitive events can have devastating outcomes for patients and their families; Keystone Heart is committed to helping physicians minimize those occurrences."
Keystone Heart began commercialization of the TriGUARD 3™ CEP device in selected TAVI centers of excellence throughout Europe in July 2020.
About Keystone Heart Ltd.
Keystone Heart, a Venus Medtech company, is a structural heart medical device company developing and manufacturing total package solutions for structural heart procedures. Headquartered in Israel, with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. We are committed to developing and delivering gold standard cardiac therapies that promote positive health economic outcomes. The company's management team has extensive experience in the fields of interventional cardiology and medical devices. Keystone Heart holds and maintains a comprehensive IP portfolio and is ISO certified.