The FDA has granted B. Braun Interventional Systems 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 designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the Bethlehem, Penn.-based company. These studies have evaluated the catheters’ use 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.
Roughly 5% of patients who receive a drug-eluting stent (DES) and more than 30% of patients who undergo bare-metal stent (BSR) implantation experience in-stent restenosis, according to studies that appeared in the European Heart Journal and the Journal of Thoracic Disease.
“We need to have a coronary DCB (drug-coated balloon) in our toolbox to treat patients,” said Dr. Jorge Saucedo, chief of cardiology at the Medical College of Wisconsin, in a news release. “This breakthrough device designation brings the technology a step closer for our use.”
“The paclitaxel-coated SeQuent Please PTCA balloon catheter has a proven track record of safety and efficacy for BMS- and DES-ISR in randomized clinical trials as well as in the largest international DCB registry with a clinical endpoint,” added Peter Flosdorf, engineering manager at B. Braun Interventional Systems. “This device is the gold standard coronary DCB based on the available clinical evidence. 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 U.S.”