Supporting data to be presented at Transcatheter Valve Therapies (TVT) Conference
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.
“Initiating this pivotal trial brings us one step closer to filling a critical need for patients undergoing TAVR”
“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).
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.
About the Study
The REFLECT (TriGuard Embolic Deflection Device to Reduced Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation) study will enroll up to 285 patients in approximately 30 centers internationally. The study will evaluate the safety and efficacy of the TriGuard™ embolic deflection device in patients undergoing transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), compared to an active control group of patients undergoing the same procedure unprotected. The primary outcome measure are combined safety endpoint at 30 days (VARC-2 defined), and hierarchical composite efficacy endpoint determined by all-cause mortality or any stroke, NIHSS (National Institutes of Health Stroke Scale) or MoCa (Montreal Cognitive Assessment) worsening and total volume of cerebral ischemic lesions detected by diffusion-weighted magnetic resonance imaging (DW-MRI), 2 to 5 days post-procedure. For more information, visit ClinicalTrials.gov, study identifier: NCT02536196.
About The TriGuard™ Cerebral Protection Device
Keystone Heart’s TriGuard™ is the only cerebral protection device designed to provide full coverage to all brain territories to minimize the risk of cerebral damage during TAVR and other cardiovascular procedures. The CE marked TriGuard™ device is shaped to accommodate anatomic variations of the aortic arch. Formed to withstand potential interface with the TAVR delivery system and other procedure related accessories, it uses a Nitinol® frame and mesh — flexible and atraumatic, yet robust and sturdy.
The TriGuard Cerebral Protection Device is placed via one of two femoral artery access ports typically used in TAVR, thereby eliminating the need for a third puncture site. It deploys rapidly, and self-positions through a small 9F catheter. It provides stable, atraumatic protection, with simple retrieval.
About Keystone Heart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures.
The Company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other cardiovascular procedures. The TriGuard product pipeline is designed to help interventional cardiologists, electrophysiologists and cardiac surgeons to preserve brain reserve while performing these procedures.
Headquartered in Israel with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. The Company’s management has extensive experience in the fields of interventional cardiology and medical devices.
For additional information, please contact us.
The TriGuard Cerebral Protection Device is not yet commercially available in the USA.
Contacts
Tellmed Strategies
Tara Dimilia, 908-369-7168
tara.dimilia@tmstrat.com
