US-based Claret Medical has obtained CE Mark approval for Sentinel Cerebral Protection System, the next generation product in its embolic protection portfolio.
Claret Medical’s Sentinel cerebral protection system (CPS) is designed for embolic protection during transcatheter aortic valve replacement (TAVR). The filter-based device provides ease of use and vessel apposition benefits relative to the company’s previous generations of the product.
The company claims that the Sentinel CPS is 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.
Claret Medical president and CEO Dr Azin Parhizgar noted interventional cardiologists told the company they would value a dual filter system that was easier to use with a more ergonomically-designed delivery system for faster device delivery and even more precise placement.
"The Sentinel CPS was developed in response to this request. We are pleased that we quickly iterated our design, made the necessary regulatory filings, and delivered a product that provides the confidence and control physicians need in order to better protect their patients by reducing the risk of stroke during TAVR procedures," Parhizgar added.
The company will launch the Sentinel CPS immediately in selected CE Mark countries.
The device will be assessed in the US under an investigational device exemption in a multicenter pivotal study involving up to 15 centers in the US and Europe.