Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device.
In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the Israel-based company said.
“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. 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,” Dr. Tamim Nazif of Columbia University Medical Center said in a prepared statement.
The first phase of the trial enrolled 258 patients and used an earlier version of the device, the TriGuard HDH, Keystone Heart said. The new phase of the trial will use the next-gen device, and is slated to enroll a total of 275 patients. The study will look to explore the role of cerebral embolic protection and whether or not it can improve the safety of TAVR procedures.
The trial is expected to be completed by October this year, and will be used to support an FDA submission, the company said.
“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. TriGuard 3 is designed to accomplish just that,” prez & CEO Chris Richardson said in a press release.
Last August, Keystone Heart said it planned to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of that year.