CAESAREA, Israel and TAMPA, Fla., May 31, 2018 /PRNewswire/ -- Keystone Heart Ltd., the leading medical device company focused on providing complete cerebral protection for patients undergoing cardiac procedures, today announced the launch of Phase II of the REFLECT trial to evaluate the safety and efficacy of the next generation of Keystone Heart -TriGUARD™ 3 Cerebral Embolic Protection device. This third-generation device is being assessed for its ability to protect the brain from emboli during transcatheter aortic valve replacement (TAVR), minimizing the risk of stroke and cerebral damage.
The REFLECT trial is a multicenter, prospective, randomized, clinical study designed to assess the safety and efficacy of comprehensive cerebral protection from emboli released during cardiovascular procedures. Phase I of this trial, which remains blinded, enrolled 258 subjects and utilized the TriGuard HDH, an earlier generation device that has CE Mark in the European Union. According to the REFLECT study chairman, Jeffrey Moses, MD, phase II of the trial, using the next generation TriGUARD 3 device, is now initiating enrollment of up to 275 additional patients. According to Dr. Moses, this trial is designed to definitively address the role of comprehensive cerebral embolic protection in improving the safety of the TAVR procedure. Trial completion is targeted for October of this year with FDA submission shortly thereafter.
"Knowing what we now know about the significant risks of stroke and other neurological injury associated with TAVR and other cardiovascular procedures, there is a clear unmet clinical need for cerebral embolic protection devices that provide complete protection of all three cerebral branches for patients undergoing these procedures," said Tamim Nazif, MD, the director of Clinical Services for the Structural Heart & Valve Center at Columbia University Medical Center and Director of Research for the Center for Interventional Vascular Therapy. "In our initial experience with TriGUARD 3™, the device appears to offer reliable, complete cerebral embolic protection, while also offering substantial improvements in ease of use and generalizability. We look forward to completing the REFLECT Trial and advancing our understanding of the benefits of this device in protecting our patients at risk of cerebral damage during heart procedures."
The number of TAVR procedures conducted annually worldwide has increased exponentially over the past 6 years.i About 94% of patients have new brain lesions after TAVR, one out of four have some neurologic impairment after TAVR, and four out of 10 have some neurocognitive worsening one month after TAVR. Pooled analysis from the Keystone Heart DEFLECT clinical studies demonstrated that brain protection with TriGuard HDH was able to significantly reduce the rate of VARC 2 defined strokes at 30 days (0% vs 6%), the worsening of neurological findings NIHSS (0% vs 19%), and showed higher incidence of totally clean brains (28% vs 8%). Moderate to mild brain injuries, which are caused by new lesions in the brain, can affect the patient's processing speed, executive function, and fundamental skills such as memory, language, and balance.ii These lesions may be related to changes in the way your brain functions or processes information, and lesions in the brain stem can impact basic body functions such as breathing, swallowing, heart rate, blood pressure, consciousness, and whether one is awake or fatigued.iii
"We believe that it is imperative to bring a cerebral embolic protection device to the market that: protects all areas of the brain while minimizing device interaction; avoids any manipulation of the arch vessels or an additional access site; is anatomy independent for universal patient application; and comes at a price point that will allow broad adoption for the majority of TAVR patients," said Chris Richardson, president and CEO, Keystone Heart, LTD. "TriGUARD 3 ™ is designed to accomplish just that."
A list of trial locations can be found here: www.keystoneheart.com
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 3™ Cerebral Protection Device is for investigational use only, and is not yet commercially available in the USA.
i http://www.onlinejacc.org/content/69/10/1215?_ga=2.226173146.1543630587.1501244593-669990718.1501244593&sso=1&sso_redirect_count=1&access_token= ii http://dx.doi.org/10.1016/j.amjcard.2016.08.013 iii http://dx.doi.org/10.1016/j.amjcard.2016.08.013
Contact:Tara DiMilia 908-369-7168 [email protected]
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The REFLECT trial is a multicenter, prospective, randomized, clinical study designed to assess the safety and efficacy of comprehensive cerebral protection from emboli released during cardiovascular procedures. Phase I of this trial, which remains blinded, enrolled 258 subjects and utilized the TriGuard HDH, an earlier generation device that has CE Mark in the European Union. According to the REFLECT study chairman, Jeffrey Moses, MD, phase II of the trial, using the next generation TriGUARD 3 device, is now initiating enrollment of up to 275 additional patients. According to Dr. Moses, this trial is designed to definitively address the role of comprehensive cerebral embolic protection in improving the safety of the TAVR procedure. Trial completion is targeted for October of this year with FDA submission shortly thereafter.
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"Knowing what we now know about the significant risks of stroke and other neurological injury associated with TAVR and other cardiovascular procedures, there is a clear unmet clinical need for cerebral embolic protection devices that provide complete protection of all three cerebral branches for patients undergoing these procedures," said Tamim Nazif, MD, the director of Clinical Services for the Structural Heart & Valve Center at Columbia University Medical Center and Director of Research for the Center for Interventional Vascular Therapy. "In our initial experience with TriGUARD 3™, the device appears to offer reliable, complete cerebral embolic protection, while also offering substantial improvements in ease of use and generalizability. We look forward to completing the REFLECT Trial and advancing our understanding of the benefits of this device in protecting our patients at risk of cerebral damage during heart procedures."
The number of TAVR procedures conducted annually worldwide has increased exponentially over the past 6 years.i About 94% of patients have new brain lesions after TAVR, one out of four have some neurologic impairment after TAVR, and four out of 10 have some neurocognitive worsening one month after TAVR. Pooled analysis from the Keystone Heart DEFLECT clinical studies demonstrated that brain protection with TriGuard HDH was able to significantly reduce the rate of VARC 2 defined strokes at 30 days (0% vs 6%), the worsening of neurological findings NIHSS (0% vs 19%), and showed higher incidence of totally clean brains (28% vs 8%). Moderate to mild brain injuries, which are caused by new lesions in the brain, can affect the patient's processing speed, executive function, and fundamental skills such as memory, language, and balance.ii These lesions may be related to changes in the way your brain functions or processes information, and lesions in the brain stem can impact basic body functions such as breathing, swallowing, heart rate, blood pressure, consciousness, and whether one is awake or fatigued.iii
"We believe that it is imperative to bring a cerebral embolic protection device to the market that: protects all areas of the brain while minimizing device interaction; avoids any manipulation of the arch vessels or an additional access site; is anatomy independent for universal patient application; and comes at a price point that will allow broad adoption for the majority of TAVR patients," said Chris Richardson, president and CEO, Keystone Heart, LTD. "TriGUARD 3 ™ is designed to accomplish just that."
A list of trial locations can be found here: www.keystoneheart.com
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 3™ Cerebral Protection Device is for investigational use only, and is not yet commercially available in the USA.
i http://www.onlinejacc.org/content/69/10/1215?_ga=2.226173146.1543630587.1501244593-669990718.1501244593&sso=1&sso_redirect_count=1&access_token= ii http://dx.doi.org/10.1016/j.amjcard.2016.08.013 iii http://dx.doi.org/10.1016/j.amjcard.2016.08.013
Contact:Tara DiMilia 908-369-7168 [email protected]
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SOURCE Keystone Heart Ltd.
