Medical devices maker Keystone Heart has started phase II of its Reflect trial assessing the safety and efficacy of its third-generation TriGuard cerebral embolic protection device.
Image: The trial will evaluate the the safety and efficacy of the next-generation Keystone Heart –TriGUARD 3 cerebral embolic protection device. Photo: courtesy of Keystone Heart.
The trial will assess TriGUARD 3’s potential in protecting the brain from emboli during transcatheter aortic valve replacement (TAVR), reducing the risk of stroke and cerebral damage.
Keystone has designed the multicenter, prospective, randomized and clinical study to evaluate the safety and efficacy of comprehensive cerebral protection from emboli released during cardiovascular procedures.
The phase I of this trial, which remains blinded, recruited 258 subjects and used the TriGuard HDH, an earlier generation CE mark approved device.
Reflect study chairman Dr Jeffrey Moses said the phase II of the trial, using the next generation TriGUARD 3 device, will recruit up to 275 additional patients.
The trial will help determine the role of comprehensive cerebral embolic protection in improving the safety of the TAVR procedure.
The company plans to complete the trial by October this year, and the results from the trail will be used to submit marketing application with the US Food and Drug Administration (FDA).
Keystone Heart president and CEO Chris Richardson 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.”
Based in Israel, Keystone Heart is engaged in the development and manufacturing of cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures.