Keystone Heart Accelerates Trials for Next-Generation TriGuard 3 Cerebral Embolic Protection Device
August 7, 2017—Keystone Heart Ltd. recently announced plans to initiate clinical trials for a new version of the company's TriGuard 3 cerebral embolic protection device, a third-generation device that incorporates technological improvements over earlier versions. The TriGuard products provide full coverage of all cerebral vessels and protect the brain from embolic debris during transcatheter aortic valve replacement (TAVR) and other heart procedures. The company has accelerated the development program to enable initiation of third-generation device trials by the end of the year.
According to the company, the new TriGuard 3 device is designed for universal patient application by being anatomy independent and not interacting with any of the cerebral branch vessels. TriGuard 3 has an over-the-wire design with an 8-F sheath.
In the company's press release, Jeffrey Moses, MD, commented, "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 postprocedure 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."
Keystone Heart noted that 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 TAVR with TriGuard.
All patients enrolled in the current REFLECT study, a multicenter, phase 2/3, randomized, interventional, single-blind clinical study designed to evaluate the safety and efficacy of the second-generation TriGuard embolic deflection device, will continue to be evaluated postprocedurally 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.
The second-generation TriGuard has received CE Mark approval and is being used at select centers in Europe. The TriGuard cerebral protection device is not yet commercially available in the United States, advised Keystone Heart.