Keystone Heart Ltd to Accelerate Trials for Advanced Device to Protect Brain During Heart Procedures

New third-generation cerebral embolic protection device offers improvements to further guard the brain from emboli during heart procedures including TAVR

Keystone Heart

CAESAREA, Israel, and TAMPA, Florida — August 1st, 2017 — Keystone Heart Ltd., an emerging medical device company focused on developing cerebral protection devices for patients undergoing cardiac procedures, today announced plans to initiate clinical trials for a new, advanced version of Keystone Heart TriGuard™ cerebral embolic protection device. This third-generation device, TriGuard 3, will continue the TriGuard legacy of being the only device designed to provide full coverage of all cerebral vessels while protecting the brain from embolic debris resulting from heart procedures, and also offer technological improvements over earlier versions of the device. The company has accelerated the development program to enable initiation of third-generation device trials by the end of the year.

“Our next generation device, TriGuard 3 incorporates ease-of-use and anatomy independence, while eliminating device and cerebral branch interaction. This is exactly what our investigators have been asking for in a cerebral embolic protection device.” said Chris Richardson, president and CEO, Keystone Heart, LTD. “We are grateful to our study researchers, clinical advisors and internal staff for the outstanding feedback and support that facilitated the creation of this next-generation device, which we believe will ultimately further improve patient lives.”

Like earlier TriGuard devices, TriGuard 3 is designed to protect the brain from emboli during transcatheter aortic valve replacement (TAVR) and other heart procedures to minimize the risk of stroke and other potential damage to the brain. Unique to its design, TriGuard 3 is focused on ease of use, and an ability to minimize interactions with other heart procedure devices. The new device is designed for universal patient application by being anatomy independent and doesn’t interact with any of the cerebral branch vessels. TriGuard 3 incorporates an over the wire design via an 8 fr sheath.

“We need the right tools to best combat the risk of stroke and neurological damage associated with TAVR and other cardiovascular procedures,” said Jeffrey Moses, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, director of Interventional Cardiac Therapeutics at New York-Presbyterian Hospital/Columbia University Medical Center, and director of Advanced Cardiac Therapeutics at St. Francis Heart Center (Roslyn, NY). “We know that embolic debris resulting from these procedures can have a grave impact on how post-procedure patients function in their daily lives. Having personally been involved in TriGuard 3 testing, the new improvements to TriGuard enhance its ability to become the optimal design for cerebral embolic protection.”

The number of TAVR procedures conducted in the US each year has increased exponentially in the past 6 years, with more than 24,000 conducted in 2015 according to a report issued in March 2017i. About 94% of patients have new brain lesions after TAVR, one out of four have some neurologic impairment after TAVR, and 4 out of 10 have some neurocognitive worsening one month after TAVR. 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

Previously released data demonstrate significantly reduced stroke rates, as well as significantly reduced total lesion volume, for patients with complete coverage of all cerebral branches using the second-generation TriGuard device compared to those who were unprotected. These data are based on a pooled analysis of three trials with a total of 142 patients undergoing TAVR with TriGuard iv.

All patients enrolled in the current REFLECT study, a multi-center, Phase 2/3, randomized, interventional, single-blind clinical study designed to evaluate the safety and efficacy of the second-generation Keystone Heart TriGuard embolic deflection device, will continue to be evaluated post-procedure, and results will remain blinded. The trial will not enroll any additional patients in order to initiate the TRIFLECT study, which will evaluate TriGuard 3.

About Keystone Heart TriGuard Devices

Keystone Heart's TriGuard™ devices are the only cerebral protection devices designed to provide full coverage to all brain territories to minimize the risk of cerebral damage during TAVR and other cardiovascular procedures.

TriGuard™ devices are 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 catheter. It provides stable, atraumatic protection, with simple retrieval. CE Mark was granted to the second-generation device, which is being utilized at select centers in Europe.

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.

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The TriGuard Cerebral Protection Device is not yet commercially available in the USA.