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B. Braun Interventional Systems

B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study

March 31, 2021 By Sean Whooley

B. Braun Interventional Systems Infraredx

B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a trial for the B. Braun SeQuent Please ReX. Bethlehem, Pa.-based BIS, a B. Braun affiliate, and Infraredx, a Nipro company, will work together to accelerate the FDA investigational device exemption (IDE) clinical trial for the SeQuent Please ReX drug-coated PTCA […]

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: B. Braun Interventional Systems, Infraredx

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

August 2, 2019 By Nancy Crotti

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 […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Uncategorized Tagged With: B. Braun Interventional Systems, FDA

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