B. Braun’s Balloon Catheter Receives Breakthrough Designation

The FDA has handed B. Braun Interventional Systems breakthrough designation for its SeQuent Please ReX drug-coated balloon catheter for treating coronary in-stent restenosis.

The device is coated with paclitaxel, a chemotherapy drug used for treating lung, ovarian and breast cancer, as well as the rare cancer Kaposi sarcoma.

In-stent restenosis is the gradual re-narrowing of a coronary artery following stent implantation.