FDA Clears Cagent Vascular’s Balloon Catheter

Cagent Vascular has earned 510(k) clearance from the FDA for its Serranator angioplasty balloon catheter for treating peripheral artery disease.

The device is the first cleared by the FDA that incorporates serration technology with a balloon that expands as internal pressure rises.

The device allows for low-pressure angioplasty and can treat a variety of lesion types, including calcified arteries.