IDE approval enables the company to initiate a pivotal clinical trial evaluating the AMS for the closure of femoral arterial and femoral venous access sites. The company plans to enroll patients undergoing catheter-based interventional procedures requiring large-bore femoral arterial or femoral venous access.

In total, Maple Grove, Minnesota-based xDot plans to enroll 266 subjects, including roll-in subjects. It plans for follow-up through 30 days post-procedure. Dr. Rahul P. Sharma (Stanford Healthca