CAESAREA, Israel and TAMPA, Fla., Feb. 27, 2017 /PRNewswire/ -- Keystone Heart Ltd., an emerging medical device company focused on developing cerebral embolic protection devices for patients undergoing cardiac procedures, applauds the members of the FDA's Circulatory System Devices Panel that convened this past week for their acknowledgement of the need for cerebral protection following transcatheter aortic valve replacement (TAVR) surgery.
"The statements shared by this FDA panel support the need for greater awareness of the risk of brain injury following cardiac procedures, and clearly demonstrate the need for interventional options to keep patients safe," said M. Pauliina Margolis, M.D., Ph.D., Chief Medical Officer, Keystone Heart. "Further, we were pleased that their recommendations dovetail the methodology of our current US pivotal trial REFLECT, utilizing the TriGuard Cerebral Embolic Protection Device."
The company wholly supports, in theory and practice, the panel's recommendations for clinical trials related to evaluating device efficacy. These recommendations include: clinical endpoints of death and stroke, the need for evaluation of all brain territories, inclusion of neurological testing beyond diffusion weighted magnetic resonance imaging (DW-MRI) and use of consistent measurement criteria across studies.
While Keystone Heart's current trials already account for the majority of these recommendations, the panel's feedback are also supported by research guidelines developed by The Neurologic Academic Research Consortium (NeuroARC) that establish and provide standardized consensus definitions for neurologic endpoints in cardiovascular clinical trials. Just released in the Journal of American College of Cardiology and the European Heart Journal, these guidelines highlight a growing body of evidence of the existence of "covert" brain injury to patients undergoing TAVR.
Numerous studies have demonstrated that, without the use of a brain protection device, 58% to 100% of patients have new brain lesions following TAVR. These studies include NeuroTAVR, which shows that 94% of patients had new lesions in the brain following the TAVR procedure, 22.6% of patients had new neurologic impairment post TAVR, and 41% of patients had declining neurocognition at 30 days when compared to pre TAVR scores in US.
This past week's hearing evaluated Sentinel™ Cerebral Protection System (CPS), which is being developed by Claret Medical™, which requested de novo classification, no formal votes were taken.
About The TriGuard™ Cerebral Embolic 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 Embolic 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.
The TriGuard Cerebral Embolic Protection Device has been granted the CE Mark in the European Union and is commercially available in Europe. In the United States, the device is currently available for investigational use only.
About Keystone Heart
Keystone Heart Ltd. is a medical device company developing and manufacturing cerebral embolic 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, 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 or visit: www.keystoneheart.com.
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SOURCE Keystone Heart Ltd.