Encouraging outcomes observed in Europe for the TriGUARD 3™ Cerebral Embolic Protection Device During Transcatheter Heart Procedures
TAMPA, Fla., Oct. 27, 2021 /PRNewswire/ -- Keystone Heart Ltd., a Venus Medtech Company, today announced a key milestone in Europe with the TriGUARD 3 Cerebral Embolic Protection (CEP) Device. The device was granted CE mark in March of 2020 and, since launch, utilized in fourteen countries with zero physician-reported strokes.
The TriGUARD 3 CEP device is the only CE Marked product designed to minimize the risk of cerebral damage during transcatheter heart procedures, including Transcatheter Aortic Valve Implantation (TAVI), by covering and protecting all three major cerebral aortic arch vessels while deflecting embolic debris downstream. The state-of-the-art Nitinol frame and dome-shaped mesh deflector are 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. "We incorporated the TriGUARD 3 CEP device into our last two TAVI training courses," stated Professor Alain Cribier, Interventional Cardiologist and Inventor of the TAVI procedure. "The device was simple to advance in the aortic arch, easily achieving optimal protection of all three vessels. I appreciate the lack of interference the TriGUARD 3 device has with the TAVI systems."
Today, Transcatheter Aortic Valve Implantation (TAVI) is the standard of care for the replacement of stenotic aortic heart valves. Unfortunately, TAVI has some known risks. One of the major concerns is the possibility of embolic material being dislodged during the procedure and traveling to the cerebral circulation. This material can increase a patient's risk of cerebral damage, including the possibility of stroke. Even though TAVI has improved outcomes for patients with stenotic aortic heart valves, stroke associated with the procedure remains a significant risk. The TriGUARD 3 CEP device is designed to minimize that risk. Antonio Colombo, MD, Interventional Cardiologist and first to perform TAVI in Italy, commented, "We cannot dismiss the indirect evidence that protecting the brain during TAVI may limit neurological damage. The TriGUARD 3 CEP device provides complete three-vessel coverage with minimal need for vessel manipulation to divert debris downstream and away from the brain."
"Before the European launch, we enhanced our manufacturing process along with training materials to facilitate physicians' proper delivery and implant technique with the device. We are pleased to report that physicians using the TriGUARD 3 CEP device confirm the positive impact those changes have had on TriGUARD 3 usability and three-vessel coverage," Stated Steve Sandweg, Keystone Heart, General Manager.
Keystone Heart will continue expanding commercialization efforts with the TriGUARD 3 Cerebral Embolic Protection device in 2021, focusing on major structural heart facilities throughout Europe.
The TriGUARD 3 Cerebral Embolic Protection device is CE Marked. Currently, the TriGUARD 3 Cerebral Embolic Protection device is not commercially available in the US.
About Keystone Heart Ltd.
Keystone Heart Ltd., a Venus MedTech Company, is a medical device company developing and manufacturing devices for the structural heart space. Headquartered in Israel, with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research.
For additional information on Keystone Heart, visit www.keystoneheart.com
Media contact:
Jennifer Anderson
Phone: 720-471-4625
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