CAESAREA, Israel & TAMPA, Fla.--(BUSINESS WIRE)--Keystone Heart Ltd., an emerging medical device company focused on developing cerebral protection devices for patients undergoing cardiac procedures, today announced enrollment of the first patient in a pivotal U.S. regulatory study to evaluate the safety and efficacy of Keystone Heart TriGuard™ embolic deflection device. The device is being assessed for its ability to protect the brain from emboli during transcatheter aortic valve replacement (TAVR), minimizing the risk of cerebral damage. The study, REFLECT, is a multicenter, Phase 2/3, randomized, interventional, single-blind clinical study.
“The risk of stroke and other neurological damage is a very serious, yet potentially preventable complication associated with TAVR and other cardiovascular procedures,” said Study chair Jeffrey Moses, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, director of Interventional Cardiac Therapeutics at NewYork-Presbyterian Hospital/Columbia University Medical Center, and director of Advanced Cardiac Therapeutics at St. Francis Heart Center (Roslyn, NY). “Through research of devices such as TriGuard, we hope to prevent future TAVR patients from experiencing complications that can have a grave impact on how they are able to function in their daily lives.”
Dr. Moses will present the clinical trial strategy for REFLECT at the Transcatheter Valve Therapies (TVT) Conference (Chicago, IL, USA, June 16-18, 2016).
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Also at the TVT Conference, Joachim Schofer, MD, PhD, of Albertinen Heart Center (Hamburg, Germany) will share data that laid the groundwork for this study demonstrating significantly reduced stroke rates, as well as significantly reduced total lesion volume, for patients using TriGuard compared to those who were unprotected. This data is based on a pooled analysis of three trials with a total of 142 patients undergoing TAVR with TriGuard (N=59) vs. no protection (N=83), as previously presented at EuroPCR 2016.
“Neurologic damage due to TAVR is overlooked, and stroke is one of the most devastating complications after these procedures,” said Raj Makkar, MD, director, Interventional Cardiology, Cardiac Catherization Laboratory, Cedars-Sinai Heart Institute. “In this new study of TriGuard, we hope to reduce the risk of neurological damage, and are pleased with the success of the first patient at this time.”
The data are expected to be available in the first half of 2017.
“Initiating this pivotal trial brings us one step closer to filling a critical need for patients undergoing TAVR,” said Chris Richardson, president and CEO, Keystone Heart, LTD.
