Keystone Heart has announced plans to initiate clinical trials for a new, advanced version of its TriGuard cerebral embolic protection device. A press release reports that this 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 programme to enable initiation of third-generation device trials by the end of the year.
TriGuard 3 is designed to protect the brain from emboli during transcatheter aortic valve implantation (TAVI) and other heart procedures to minimise 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 minimise 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.
According to the press release, 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 TAVI with TriGuard.
Jeffrey Moses (Columbia University College of Physicians and Surgeons/New York-Presbyterian Hospital/Columbia University Medical Center, New York, USA), says: “We need the right tools to best combat the risk of stroke and neurological damage associated with TAVI 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.”
All patients enrolled in the current REFLECT study, a multicentre, Phase 2/3, randomised, 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.