TAMPA, Fla., Oct. 18, 2021 /PRNewswire/ -- Keystone Heart Ltd., a Venus Medtech Company, today celebrated an important achievement of treating 100 patients with the TriGUARD 3 Cerebral Embolic Protection (CEP) Device at UMC Utrecht in the Netherlands. The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and other transcatheter heart procedures.
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 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.
UMC Utrecht Heart Team members, including Professor Pieter Stella, Dr. Adriaan Kraaijeveld, and Dr. Michiel Voskuil, began using the device in July 2020 as the first commercial users globally and since then, performed 100 procedures with the TriGUARD 3 CEP device. "The primary endpoint of our case series was the absence of neurological symptoms based on assessments prior to discharge, including Stroke or transient ischemic attack (TIA), within 72 hours after TAVI", stated Pieter Stella, Associate Professor, UMC Utrecht. "During the series, only one patient had a TIA with no new lesions identified by MRI. My colleagues and I determined a vasospasm most likely caused this event."
"We also assessed the TriGUARD 3 device positioning and device-related safety outcomes, including bleeding, dissection, and other vascular complications," noted Professor Stella. "Among the 100 patients treated, successful deployment and positioning were achieved in 100% of all cases. Complete 3-vessel coverage throughout the whole procedure was achieved in 95% of cases with partial coverage reported in 5% due to procedural related issues which required access of contralateral artery by tools other than the TriGUARD 3 sheath." All performance data collected was based on physician reports of angiographic imaging assessments at critical time points. "One patient experienced a minor vascular complication caused by a local hematoma, and two patients had femoral dissections, both of which resolved without sequelae," acknowledged Professor Stella.
"Based on the positive outcomes from these initial cases, our center now uses the TriGUARD 3 device as routine standard of care for all patients undergoing intracardiac procedures," Professor Stella emphasized. "The totality of evidence from my real-world experience supports that the TriGUARD 3 CEP device provides an easy and safe treatment option for patients undergoing a TAVI procedure."
"We are encouraged to see the favorable real-world outcomes observed by Professor Stella and the UMC Utrecht Team," said Steve Sandweg, Keystone Heart General Manager. "These site reported data provide compelling evidence for EU physicians when using the TriGUARD 3 CEP device in TAVI. Since its inception, Professor Stella has been a passionate advocate of cerebral embolic protection. We look forward to working together in the future to study and quantify the clinical benefits of using the TriGUARD 3 device in other transcatheter heart procedures."
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
Jennifer.Anderson@Keystoneheart.com
