Claret Medical announced that it has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) for a multicentre study of the company’s Sentinel cerebral protection system for embolic protection during Transcatheter Aortic Valve Implantation (TAVI).
“Protecting cerebral vasculature from embolic debris liberated from multiple sources during TAVI procedures continues to be a critical safety challenge. Recent studies have validated that macroscopic material liberated during these procedures can be effectively captured and safely removed using Claret Medical’s dual filter embolic protection system,” comments Martin Leon, director of the Centre for Interventional Vascular Therapy at Columbia University Medical Centre in New York and chair of the trial’s Clinical Steering Committee. “We expect the results of the SENTINEL trial to confirm the importance of embolic debris capture and removal during TAVI and to further elucidate the neurocognitive implications of such embolic protection.”
According to a press release, the SENTINEL study will evaluate the Sentinel cerebral protection system during TAVI as compared to the standard of care. Primary endpoints include reduction in total new lesion volume by diffusion-weighted magnetic resonance imaging (DW-MRI) and rate of major adverse cardiac and cerebrovascular events (MACCE). The study will be conducted at up to 15 centres and will begin in the first quarter of 2014.
“This is another step forward in advancing our unique filter-based technology for cerebral protection during TAVI,” says Azin Parhizgar, president and chief executive officer of Claret Medical. “We look forward to initiating the study and providing physicians the confidence and control needed to capture and remove embolic debris liberated during TAVI procedures – debris that could otherwise be a source of peri-procedural stroke in this patient population.” Parhizgar continues, “I am especially pleased that our comprehensive and collaborative pre-IDE discussions allowed us to receive timely approval to conduct the first randomized clinical study in the US for evaluating the role of cerebral protection during TAVI.”