Claret's Sentinel Cerebral Protection System for TAVR Gains CE Mark Approval

January 27, 2014—Claret Medical, Inc. (Santa Rosa, CA) announced that it has received CE Mark approval for its Sentinel cerebral protection system (CPS) to provide embolic protection during transcatheter aortic valve replacement (TAVR). The product will be launched immediately in selected CE Mark countries.

According to Claret Medical, the Sentinel CPS is a filter-based system that captures and removes embolic debris that are released and travel to the brain during TAVR procedures. Sentinel CPS is a next-generation product in the company's embolic protection portfolio and provides ease-of-use and vessel apposition benefits relative to the previous generations of the product.

The company advised that in the United States, the Sentinel CPS will be evaluated under an investigational device exemption in a multicenter pivotal study conducted at up to 15 centers in the United States and Europe.

John Webb, MD, completed the first Sentinel CPS procedure. Dr. Webb is Medical Director of the Cardiac Catheterization Lab and Director of Interventional Cardiology Research at St. Paul's Hospital in Vancouver, Canada. In Claret's press release, Dr. Webb commented, “I am impressed with the overall ease of use of the Sentinel system. The new ergonomic handle makes the device very intuitive to use.”

Nicholas Van Mieghem, MD, of the Department of Interventional Cardiology at Erasmus Medical Center in Rotterdam, the Netherlands, also commented in Claret's announcement. Dr. Van Mieghem stated, “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. 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.”