CAESAREA, Israel and TAMPA, Fla., Sept. 19, 2016 /PRNewswire/ -- Keystone Heart Ltd., an emerging medical device company focused on developing cerebral protection devices for patients undergoing cardiac procedures, today announces the safety and efficacy of the TriGuard™ Cerebral Embolic Protection device when used during Transcatheter Aortic Valve Replacement (TAVR), according to preliminary findings from real-world experience of 51 patients discussed at the PCR London Valves 2016 Conference today in London, England.
Results demonstrated a significant difference in the number of patients with brain lesions incurred during the TAVR procedure with 68% of unprotected patients experiencing new lesions compared to only 20% of patients for which the TriGuard embolic deflection device was used (p=0.004), based on MRI evaluations of patients conducted by Joachim Schofer, MD, Professor, Hamburg University Cardiovascular Center and Department of structural heart disease, Hamburg, Germany.
"These data, together with previously reported positive safety, and clinically meaningful outcomes, reinforce the importance of using TriGuard to protect the brain from damage potentially incurred during TAVR procedures," said Alexandra J. Lansky, MD, Division of Cardiology, Yale School of Medicine and Yale Cardiovascular Research Group, New Haven, Connecticut, United States.
The aim of the study was to evaluate the safety and effectiveness of the TriGuard™ HDH embolic deflection device in protecting the brain from lesions during TAVR procedures compared to the current standard of care in the US and Europe, which is no cerebral protection during these procedures. The TriGuard Cerebral Protection Device is commercially available in Europe but it is not yet commercially available in the US.
In this real world study, physicians from two institutions enrolled a total of 51 patients undergoing TAVR (80± 8 years, 51% male, logistic EuroSCORE 12.6±8.3) with either transfemoral (96%) or transapical (4%) insertion. Peter R. Stella, PhD, MD, Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands enrolled 41 patients and Dr. Schofer enrolled 10, as noted above. The 10 enrolled by Dr. Schofer were were also tested with post TAVR MRI using clinical criteria, and were compared to 150 historical controls from the same institution.
Of the 51 patients protected by the TriGuard device in this study, none experienced strokes, and a successful device performance of 100% was observed without interference during TAVR procedures.
In the MRI arm of the study, additional endpoints demonstrated clear improvement in the mean number of new lesions (2.1 for unprotected historical controls vs 0.06 for protected patients, p= 0.06), mean total lesion volume (206 mm3 for unprotected historical controls vs 44 mm3 for protected patients, p=0.08) and mean single lesion volume (74 mm3 for unprotected historical controls vs 15 mm3 for protected patients, p=0.05).
TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material that enter blood circulation to the brain during transcatheter heart valve replacement or implantation. TriGuard is the only device designed to provide full coverage of all brain territories without the need for third access site during TAVI.
At the PCR London Valves conference, Dr. Lansky is also presenting an update on NeuroARC, an initiative aimed at establishing standardized neurologic endpoints for cardiovascular clinical trials to ensure clinically meaningful patient outcomes and improve the quality of clinical research. The initiative is spearheaded by a diverse working group comprised of physician and scientific leaders in interventional and structural cardiology, cardiac surgery, neurology, neuroradiology, neuropsychology, as well as clinical trialists representing academic research organizations from the US and Europe, and representatives from the medical device industry and the US Food and Drug Administration (FDA).
"Neurologic damage due to TAVR is overlooked, and protecting the brain has become a priority to improve our patients' outcomes," stated Dr. Lansky. "Consensus-driven definitions of neurologic measures will facilitate more informed benefit-risk assessments for all procedures and devices, and improve our care of patients."
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.
The TriGuard Cerebral 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 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.
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SOURCE Keystone Heart Ltd.