Claret Medical files for FDA clearance for Sentinel cerebral protection device

Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements. The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes. “Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studies incorporate a level of rigorous brain evaluation never before undertaken, including systematic and serial state-of-the-art 3-Tesla MRI neuroimaging of patients’ pre-existing cerebrovascular disease, as determined by a baseline MRI, as well as neurological, histopathological and neurocognitive evaluations. Assuming a positive outcome with the FDA, we look forward to making the Sentinel CPS available to interventional cardiologists and cardiovascular surgeons in the US soon,” president & CEO Azin Parhizgar said in a press release. Included in the FDA filing are results from the company’s completed Sentinel pivotal investigational device exemption trial of 363 TAVR patients. Data from the trial indicated a reduction in new ischemic cerebral infarcts, major adverse cardiac or cerebrovascular events, improved neurocognitive outcomes and qual...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Stroke Source Type: news