Keystone Heart, LTD.
Protecting the Brain during Cardiovascular Procedures

Transcatheter aortic valve replacement (TAVR) continues to be an effective and less invasive treatment option for patients suffering from severe aortic stenosis (AS) compared to open surgery. Although an excellent option in treating aortic stenosis, TAVR is not without its complications; cerebrovascular accidents are one of the most important and clinically significant adverse events for patients undergoing this procedure.

Keystone Heart, LTD. has made it their company mission to develop and manufacture novel devices that protect the brain from emboli to reduce the risk of brain infarcts during transcatheter aortic valve replacement (TAVR) along with other structural heart procedures. “During these cardiovascular procedures, debris from the aortic valve, ascending aorta and other sources may embolize and cause cerebral infarction. Embolic brain lesions resulting from these procedures may lead to potentially devastating outcomes—stroke, dementia and cognitive decline. 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. These lesions may be related to changes in the way the 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. The location of these lesions determines the damage and clinical symptoms, and where a lesion may occur is unpredictable,” states Chris Richardson, president and CEO of Keystone Heart, LTD.

Beginning with the original TriGUARD™ CEP device, the DEFLECT I study was presented at EuroPCR in 2013 showcasing feasibility and safety in patients undergoing TAVR.

The TriGUARD 3™ CEP device is designed to help interventional cardiologists and electrophysiologists protect the brain during cardiovascular procedures

Over the next several years, Keystone Heart, LTD. invested in additional studies and device modifications to strive toward demonstrating the clinical benefits of cerebral embolic protection. Today, a multi-center, randomized clinical trial evaluating Keystone’s latest device, the TriGUARD 3™ CEP device, is currently underway.

According to Richardson, “Upon receiving regulatory approval, the TriGUARD 3 CEP device will be the only commercially available Cerebral Embolic Protection Device delivered transfemorally and designed to protect all cerebral aortic arch vessels with no anatomical restrictions or manipulation of the cerebral vessels. The TriGUARD 3™ CEP device is designed to help interventional cardiologists and electrophysiologists protect the brain during cardiovascular procedures. The innovative Nitinol frame with dome shaped mesh deflector is designed to “self-seat” and conform to all aortic arch anatomies while providing stability to the deflection filter. The TriGUARD 3 CEP device deflection filter allows adequate blood flow to the brain while diverting emboli downstream.”

Keystone Heart, LTD. is currently enrolling patients in the REFLECT Phase II trial in the US to evaluate the safety and efficacy of the TriGUARD 3 CEP device, and anticipates completing enrollment by the end of the first quarter of 2019. It anticipates receiving FDA approval in Q3 of 2019. CE mark approval for Europe is anticipated by the end of Q2 2019.

In December 2018, Venus Medtech (Hangzhou) Inc., the preeminent Chinese transcatheter heart valve company, announced it has closed its merger with Keystone Heart LTD. “Our partnership is allowing us the unique opportunity to improve the lives of patients undergoing structural heart procedures with cerebral embolic protection today while working closely with Venus Medtech to bring new and cutting-edge therapies into the US & European markets tomorrow,” remarks Richardson, in his closing comments.