FDA Breakthrough Device Designation for B Braun’s SeQuent Please ReXn drug-coated balloon

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 [...]