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 balloon catheter, which received breakthrough device designation in 2019.
The SeQuent Please ReX drug-coated PTCA balloon catheter is designed to treat coronary in-stent restenosis (ISR), or the gradual re-narrowing of a coronary artery following stent implantation, according to a news release.
Under the collaboration, BIS and Infraredx plan to utilize both companies’ resources to pool clinical expertise and financial resources to accelerate and execute the U.S. study.
“B. Braun and Nipro have worked together over the last decade to arm vascular specialists in Europe and Asia with alternative therapies for coronary interventions,” Infraredx president & CEO Nozomu Fujita said in the release. “Our decision to also align the resources of our U.S. entities will accelerate how quickly U.S. Interventionalists will be able to access the SeQuent Please ReX technology for U.S. clinical trials.”
B. Braun has sold more than 1 million SeQuent Please drug-coated PTCA balloon catheters. The company developed the SeQuent Please ReX — a variation on the current portfolio sold outside the U.S — exclusively for the U.S. market.
“Over the last decade, together with Nipro, we have been able to develop the market for coronary drug-coated balloons by delivering high-quality clinical evidence and optimal physician and patient access,” B. Braun Melsungen AG Vascular Systems director of medical, scientific & regulatory affairs Dr. Philip Steen said. “Aligning with Infraredx to work toward bringing the SeQuent Please Technology to the U.S. marketplace through the U.S. IDE process is a logical next step to address an important unmet clinical need.”