B. Braun wins the breakthrough nod for a drug-eluting balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s drug-eluting percutaneous transluminal balloon catheter PTCA (SeQuent Please ReX) for the treatment of coronary in-stent restenosis (ISR).
The name follows 10 years of clinical studies on the drug-eluting PTCA catheters SeQuent Please, the data of which was given in peer-reviewed articles, according to the Bethlehem, Pennsylvania-based company. These studies examined the use of the catheters in a variety of indications, including in-stent restenosis in bare metal stents and drug-eluting stents, as well as in initial stenosis found in de novo lesions.
Approximately 5% of patients who receive a drug eluting stent (DES) and more than 30% of patients who undergo bare metal stent implantation (BSR) experience in-stent restenosis. This is evident from studies published in the European Heart Journal and the European Heart Journal, the Journal of Thoracic Disease.
“We need a coronary DCB (drug eluting balloon) in our tool box to treat patients,” said Dr. Jorge Saucedo, chief of cardiology at the Medical College of Wisconsin, in a press release. “This groundbreaking device name brings the technology one step closer to our use.”
“The SeQuent Please PTCA balloon catheter coated with paclitaxel has a proven track record of safety and efficacy of BMS and DES ISR in randomized clinical trials as well as in the largest international DCB registry with clinical endpoint,” added Peter Flosdorf, engineer, added manager at B. Braun Interventional Systems. “This device is the gold standard for coronary DCB based on the available clinical evidence. We are delighted that the latest generation of SeQuent Please DCB has received the pioneering device designation that will streamline the review process and timeline for making this important treatment option available to eligible patients in the United States. “