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Home » B. Braun’s Balloon Catheter Receives Breakthrough Designation

B. Braun’s Balloon Catheter Receives Breakthrough Designation

August 5, 2019

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.

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