C.R. Bard Lands Additional Indication for Drug-Coated Balloon Catheter

C.R. Bard received premarket approval from the FDA for its drug-coated balloon CTA catheter for a new indication for end-stage renal disease.

The device is the first and only drug-coated balloon approved for ESRD patients with stenotic lesions. The device was previously approved for treatment of superficial femoral artery and popliteal artery disease.

The FDA based its approval on an investigational device exemption clinical trial that showed sustained clinical benefit and safety compared to patients using uncoated balloons.