Keystone Heart said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year.
The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device.
Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage.
The TriGuard 3 is designed to be anatomy independent and for a universal patient population without interacting with any of the cerebral branch vessels, and will incorporate an over the wire design on an 8 french sheath, the company said.
“We need the right tools to best combat the risk of stroke and neurological damage associated with TAVR and other cardiovascular procedures. 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,” Dr. Jeffrey Moses of the Columbia University College of Physicians and Surgeons said in a prepared statement.
“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. 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,” prez & CEO Chris Richardson said in a press release.
Keystone Heart said that patients enrolled in the Reflect study of its 2nd-gen TriGuard device will continue to be evaluated post-procedure, with results remaining blinded, but that the trial would cease enrollment in order for the company to initiate the Triflect study of its TriGuard 3.
In March, Keystone Heart said it inked a partnership deal with Venus Medtech covering China and other Asian markets.
Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device.