REFLECT Trial aims to establish efficacy of Keystone Heart’s TriGuard™ investigational device designed to reduce risk of stroke during TAVR.
Recent years have seen transcatheter approaches to aortic valve replacement (TAVR) literally bursting onto the scene. These new technologies offer a catheter-based procedure, particularly advantageous for patients deemed too high risk for conventional surgery. However, TAVR is not without its own risks, particularly of brain injury caused by debris travelling through the bloodstream to the brain.
First appearing on our pages back in 2013, Keystone Heart’s TriGuard™ is designed to reduce the amount of embolic debris for patients undergoing TAVR. The TriGuard name hints at the claim that this minimally invasive filter-type device covers all three aortic arch cerebral “take-off” vessels. Furthermore it is shaped to accommodate anatomic variations of the aortic arch in order to provide full coverage to all brain territories. It is placed via one of the femoral artery access ports typically used in TAVR, thereby eliminating the need for a third puncture site.
The international clinical trial, called REFLECT, started recruiting last year and will ultimately provide pivotal data that Keystone Heart hopes will support its U.S. FDA approval. The multi-center study follows on from DEFLECT I, II and III trials, results from which have already been presented at major congresses including EuroPCR and ACC.
Interestingly, despite remaining an investigational device in the United States, TriGuard was CE mark approved as far back as 2013 as we reported at the time here.
“As physicians, we see firsthand the debilitating effects of brain injury following TAVR can have on our patients,” states Mubashir Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery, surgical director of structural heart and principal investigator for the trial at PinnacleHealth. “PinnacleHealth CardioVascular Institute is honored to be selected for this elite global trial, studying a major patient safety initiative.”
“This device presents the opportunity to minimize brain injury following TAVR and supports our goal to preserve quality of life,” states Hemal Gada, MD, MBA, interventional cardiologist and medical director of structural heart at PinnacleHealth.
Source: PR Newswire