The US FDA has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated balloon catheter (B Braun Interventional Systems) for the treatment of coronary in-stent restenosis. A press release reports that SeQuent Please ReX is the latest generation coronary drug-coated balloon catheter developed by B Braun.

Ten years of extensive clinical study evaluations have been conducted on SeQuent Please drug-coated catheters and the data were reported in peer-reviewed articles. These studies have evaluated use of the catheters in a variety of indications, including in-stent restenosis for bare metal stents and drug-eluting stents, as well as for initial stenosis detected in de novo lesions.

Breakthrough Device Designation from the FDA is granted to certain medical devices and device-led combination products that provide for a more effective treatment of life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorisation.

Peter Flosdorf, engineering manager at B Braun Interventional Systems, says: “The paclitaxel-coated SeQuent Please balloon catheter has a proven track record of safety and efficacy for bare metal stent- and drug-eluting stents in-stent restenosis in randomised clinical trials as well as in the largest international drug-coated balloon registry with a clinical endpoint. This device is the gold standard coronary drug-coated ballon based on the available 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 USA.”