Claret Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a multicentre study of its Sentinel Cerebral Protection System (CPS) for embolic protection during transcatheter aortic valve replacement (TAVR).
The Sentinel study is aimed at evaluating the Sentinel CPS during TAVR as compared with the standard of care.
It will be conducted at up to 15 centres 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 CE-Marked Sentinel CPS is claimed to be the only filter-based system in the market that captures and removes embolic debris that is released and travels to the brain during TAVR procedures.
Columbia University Medical Center Center for Interventional Vascular Therapy director in New York Dr Martin Leon said: "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.
"We expect the results of the Sentinel trial to confirm the importance of embolic debris capture and removal during TAVR and to further elucidate the neurocognitive implications of such embolic protection."
Last month, the company obtained CE Mark approval for the Sentinel for embolic protection during TAVR.
Claret Medical president and CEO Dr Azin Parhizgar said: "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.
"I am especially pleased that our comprehensive and collaborative pre-IDE discussions allowed us to receive timely approval to conduct the first randomised clinical study in the US for evaluating the role of cerebral protection during TAVR."
According to GlobalData estimates, the US embolic systems market was valued at $224.8m in 2012 and is expected to grow at a CAGR of 7.1% to reach $363.3m by 2019.