CAESAREA, Israel and PARIS, May 19, 2016 /PRNewswire/ -- EuroPCR -- Keystone Heart has announced that a pooled analysis of three prospective and comparable clinical studies of patients undergoing TAVR in US and Europe, further corroborates that TriGuard™ protection significantly reduces stroke rate, lowers CNS infarction and reduces total lesion volume, without adversely impacting the safety of the TAVR procedure.
The aim of the analysis was to evaluate the safety and effectiveness of the TriGuard™ HDH embolic deflection device compared to no protection. This was done in a pooled analysis of three prospective and comparable clinical studies of patients undergoing transcatheter valve implantation (TAVR) in the US and Europe. Dr. Alexandra J. Lansky (Division of Cardiology, Yale School of Medicine and Yale Cardiovascular Research Group, New Haven, CT, USA) presented the analysis earlier at EuroPCR, during the late breaking trials session on new valvular interventions and enabling technologies.
The patient level data was pooled from a total of 142 patients undergoing TAVR with TriGuard™ protection (N=59) vs. no protection (N=83). The data was pooled from three trials (DEFLECT I, DEFLECT III and Neuro TAVR) evaluating neurologic complications with and without cerebral protection during TAVR. All three trials mandated pre-discharge diffusion weighted MRI (DW-MRI) and performed serial neurologic assessments using the same methods and core laboratories.
Key results were as follows:
- TriGuard protection significantly reduced in hospital VARC2 defined stroke (0% vs. 6.0%, p=0.05)
- TriGuard protection significantly reduced stroke rate defined by worsening NIHSS (National Institutes of Health Stroke Scale) with DW-MRI lesions (0% vs. 19%, p=0.002)
- TriGuard protected patients showed higher absence of CNS infarction (28% vs. 8%, p=0.008)
- Total lesion volume was reduced significantly with TriGuard vs. no protection (315+620mm3 vs. 511+893mm3, p=0.04)
- None of the TriGuard protected patients had worsened NIHS score, while 17.1% of the patients without protection had worsened NIHS score (p=0.001)
These clinically meaningful outcomes, clearly demonstrate the importance of using TriGuard, and the potential consequences of unprotected procedures.
Keystone Heart's TriGuard™ is the only cerebral protection device specifically designed to provide full coverage to all aortic arch takeoffs. The CE marked TriGuard™ Cerebral Protection Device is not yet commercially available in the USA.
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, 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.
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SOURCE Keystone Heart