Claret Medical, Inc., a developer of innovative solutions for cerebral protection during structural heart interventions, vascular interventions, and cardiac surgery procedures, announced that it has received CE Mark for the Sentinel™ Cerebral Protection System (CPS) for embolic protection during Transcatheter Aortic Valve Replacement (TAVR). The product will launch immediately in selected CE Mark countries.
Dr. John Webb, Medical Director of the Cardiac Catheterization Lab and Director of Interventional Cardiology Research at St. Paul's Hospital in Vancouver, Canada completed the first Sentinel CPS procedure. "I am impressed with the overall ease of use of the Sentinel System. The new ergonomic handle makes the device very intuitive to use."
The Sentinel CPS is the next generation product in Claret's embolic protection portfolio and provides ease of use and vessel apposition benefits relative to the previous generations of the product. The Sentinel CPS is 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.
"Cerebrovascular events remain a major concern during TAVR due to the macroscopic material that is liberated during the procedure from catheter manipulation as well as from the burden of atheroma in the vasculature and the native valve," said Dr. Nicholas Van Mieghem, Department of Interventional Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands. "Other devices deflect debris downstream but do not remove it from the circulation. Since studies have shown that embolic debris traveling to the brain can be captured in more than 75% of procedures when a filter is used, embolic protection could become the standard of care in TAVR."
"Interventional cardiologists told us 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," said Azin Parhizgar, PhD, President and CEO of Claret Medical. "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."
Claret Medical has been the leader in cerebral protection during TAVR in the European Union since 2011. In the United States, the Sentinel CPS will be evaluated under an investigational device exemption (IDE) in a multicenter pivotal study involving up to 15 centers in the US and Europe.