Proceeds Will Fund Randomized, Pivotal SENTINEL Trial to Study How
Cerebral Protection May Reduce the Incidence of Stroke in Transcatheter
Aortic Valve Replacement (TAVR)
Proceeds will be used primarily to complete the U.S. pivotal trial of the company’s Sentinel™ Cerebral Protection System (CPS) for embolic protection during transcatheter aortic valve replacement (TAVR), which received Investigational Device Exemption (IDE) approval earlier this year.
The Sentinel CPS is the only filter-based system on the market that both captures and removes embolic debris released during TAVR procedures that could otherwise be a source of peri-procedural stroke. The system has been used in more than 800 procedures worldwide to date.
“Many consider the stroke rate in TAVR concerning, especially as clinicians look to bring the benefits of TAVR to lower risk and younger patients,” said
“The SENTINEL trial will evaluate the role of the Sentinel CPS in reducing the number and size of new ischemic lesions in the brain and their potential impact on patients’ neurocognitive function,” said
The company is also embarking upon two other studies of structural heart procedures that could benefit from the use of the Sentinel CPS in reducing cerebrovascular events during complex surgical and transcatheter procedures.
About Claret Medical
Claret Medical is a privately-held company focused on innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures. The company is currently focusing product development and clinical research on addressing the problem of stroke during TAVR, a significant unmet clinical need. For more information: www.claretmedical.com.
CAUTION: Investigational Device. Limited by
Source: Claret Medical