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.
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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.
