The FDA has cleared Boston Scientific’s FilterWire EZ™ Embolic Protection System for use in carotid artery stenting procedures. According to the company, the device, designed to catch embolic debris from reaching the brain, is currently “the market-leading embolic protection device for carotid artery stenting procedures outside the U.S.”
From the press release:
The FilterWire EZ System is designed to efficiently capture plaque and other embolic material that may dislodge during stent implantation and prevent it from traveling into the microvasculature where it could pose an increased risk for stroke or heart attack. The device features simplified filter sizing — one size can be placed in vessel diameters between 3.5 mm and 5.5 mm — and is designed for easy preparation, delivery and retrieval. The safety and performance of the FilterWire EZ System was evaluated in the CABERNET Trial in conjunction with the recently approved NexStent® Carotid Stent and Monorail® Delivery System. With the new carotid indication, the FilterWire EZ Embolic Protection System can now be used in the U.S. to treat patients with carotid artery disease who are at high risk for surgery.