B. Braun's next-generation SeQuent Please PTCA balloon catheter awarded FDA breakthrough device designation for coronary in-stent restenosis

B. Braun announced Thursday that the FDA has granted 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 device is B. Braun's latest generation coronary drug-coated balloon (DCB) catheter.

B. Braun noted that extensive clinical study evaluations have been conducted in the past on SeQuent Please drug-coated PTCA catheters evaluating their use in a variety of indications, including in-stent restenosis for bare metal stents (BMS) and drug-eluting stents (DES), as well as for initial stenosis detected in de novo lesions.

Peter Flosdorf, engineering manager at B. Braun Interventional Systems, remarked that "the paclitaxel-coated SeQuent Please PTCA balloon catheter has a proven track record of safety and efficacy for BMS- and DES-ISR in randomised clinical trials as well as in the largest international DCB registry with a clinical endpoint. This device is the gold standard coronary DCB based on the available clinical evidence." He added "we are excited that the latest generation SeQuent Please DCB has received breakthrough device designation, which will streamline the review process and timeline for bringing this important treatment option to appropriate patients in the US."