B. Braun wins breakthrough nod for drug-coated balloon catheter

The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR).

The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the Bethlehem, Penn.-based company. These studies have evaluated the catheters’ use in a variety of indications, including in-stent restenosis for bare-metal stents and drug-eluting stents, as well as for initial stenosis detected in de novo lesions.

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