Claret Medical has obtained Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a multicenter study of its Sentinel Cerebral Protection System (CPS) for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
The SENTINEL study will evaluate the Sentinel CPS during TAVR as compared to the standard of care. The study will be conducted at up to 15 centers and will begin in the first quarter of 2014.
The 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 next generation product in Claret’s embolic protection portfolio, Sentinel CPS provides ease of use and vessel apposition benefits relative to the previous generations of the product.
The Sentinel CPS is claimed to be the only filter-based system on the market that captures and removes embolic debris that is released and travels to the brain during TAVR procedures.
Earlier in January 2014, the company obtained CE Mark approval for the Sentinel for embolic protection during TAVR.
Claret Medical president and CEO Dr Azin Parhizgar said this is another step forward in advancing the company’s unique filter-based technology for cerebral protection during TAVR.
"We look forward to initiating the study and providing physicians the confidence and control needed to capture and remove embolic debris liberated during TAVR procedures – debris that could otherwise be a source of peri-procedural stroke in this patient population," Dr Parhizgar added.
"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 TAVR."