B. Braun to Collaborate With Infraredx on the IDE Clinical Trial for the SeQuent Please ReX DCB

March 31, 2021—B. Braun Interventional Systems Inc. announced that the company will collaborate with Infraredx, a Nipro Company, to accelerate the FDA investigational device exemption (IDE) clinical trial for the B. Braun SeQuent Please ReX drug-coated balloon (DCB) catheter for percutaneous transluminal coronary angioplasty (PTCA). The companies will leverage shared resources to accelerate the initiation of the United States clinical trial of the device to study the treatment of coronary in-stent restenosis.

B. Braun and Infraredx will pool clinical expertise and financial resources to execute the United States study.

The company noted that the collaboration extends the long-term global cooperation between the B. Braun Group of Companies and Japan-based Nipro Corporation to advance coronary artery disease management.

The SeQuent Please ReX, a variation to B. Braun’s SeQuent Please DCB for PTCA marketed outside the United States, was developed exclusively for the United States market, and represents the most recent development in the B. Braun DCB portfolio.

The SeQuent Please ReX DCB received FDA Breakthrough Device designation in 2019.