FDA Greenlights Pivotal Trial for New Vascular Closure Device

The U.S. FDA has granted approval for xDot Medical to begin a pivotal clinical trial for its xDot Access Management System (AMS). This device is designed to close large-bore femoral arterial and venous access sites, which are often used in catheter-based interventional procedures. The multicenter study will involve 266 patients and track their progress over 30 days.