The FDA has granted B. Braun Interventional Systems Inc. breakthrough device designation for its SeQuent Please ReX drug-coated PTCA balloon catheter, the company announced August 1.
The latest-generation SeQuent catheter, designed for the treatment of coronary in-stent restenosis (ISR), has been a long time coming, according to B. Braun. In a statement the company said it had been conducting “extensive clinical study evaluations” on its drug-coated PTCA catheters for a decade, testing the catheters for a variety of indications including ISR for bare-metal stents and drug-eluting stents.
“We need to have a coronary drug-coated balloon in our toolbox to treat patients,” Jorge Saucedo, chief of cardiology at the Medical College of Wisconsin, said in the statement. “This breakthrough device designation brings the technology a step closer for our use.”
The FDA grants a product breakthrough designation if the agency believes it could have a significant, immediate impact on patients. The SeQuent catheter will be fast-tracked through FDA assessment and review while preserving the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorization.
Peter Flosdorf, engineering manager at B. Braun, called his team’s device the “gold standard coronary drug-coated balloon” based on today’s clinical evidence.
“We are excited that the latest generation SeQuent Please drug-coated balloon has received breakthrough device designation, which will streamline the review process and timeline for bringing this important treatment option to appropriate patients in the U.S.,” he said.