Claret Medical, a developer of 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 for embolic protection during transcatheter aortic valve implantation (TAVI). The product will launch immediately in selected CE mark countries.
John Webb, medical director of the Cardiac Catheterisation Lab and director of Interventional Cardiology Research at St. Paul’s Hospital in Vancouver, Canada, completed the first Sentinel cerebral protection system 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.”
According to a press release, the Sentinel cerebral protection system 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 cerebral protection system is the only filter-based system on the market that captures and removes embolic debris that is released and travels to the brain during transcatheter aortic valve implantation procedures.
“Cerebrovascular events remain a major concern during transcatheter aortic valve implantation 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,” says Nicholas Van Mieghem, Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands. “Other devices deflect debris downstream but do not remove it from the circulation. Since studies have shown that embolic debris travelling 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 transcatheter aortic valve implantation.”
In the United States, the Sentinel cerebral protection system will be evaluated under an investigational device exemption in a multicentre pivotal study involving up to 15 centres in the USA and Europe, the press release concludes.