B. Braun Interventional Systems, an Affiliate of B. Braun Medical Inc., Receives Breakthrough Device Designation Status from the FDA for SeQuent Please ReX Drug Coated PTCA Balloon Catheter
BETHLEHEM, PA – August 1, 2019 – B. Braun Interventional Systems Inc. (BIS) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR).
SeQuent Please ReX is the latest generation coronary drug-coated balloon (DCB) catheter developed by B. Braun, the worldwide market leader in drug-coated PTCA catheters. Ten years of extensive clinical study evaluations have been conducted on SeQuent Please drug-coated PTCA 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 (BMS) and drug-eluting stents (DES), as well as for initial stenosis detected in de novo lesions.
In-stent restenosis is the gradual re-narrowing of a coronary artery following stent implantation, and remains a challenge in the interventional community. Despite a significant reduction in ISR when using a drug-eluting stent over a bare metal stent, there still are a subset of patients in which ISR persists. Approximately 5% of patients who receive a DES and more than 30% of patients who undergo BMS implantation experience ISR.1
“We need to have a coronary DCB in our toolbox to treat patients,” said Dr. Jorge Saucedo, Chief of Cardiology at the Medical College of Wisconsin, “This Breakthrough Device Designation brings the technology a step closer for our use.”
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 authorization.
“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. This device is the gold standard coronary DCB based on the available clinical evidence,” said Peter Flosdorf, Engineering Manager at
B. Braun Interventional Systems. “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.”
About B. Braun Interventional Systems
B. Braun Interventional Systems offers interventional solutions designed with the patient in mind. Many of the products offered have been developed in response to the needs of physicians, technicians, and nurses. The company is committed to delivering safety, precision and convenience to interventional procedures. B. Braun Interventional Systems Inc. is part of the
B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, Pa., and includes B. Braun Medical Inc., Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Interventional Systems Inc., visit www.bisusa.org/about-us.
 Byrne R et al. Eur Heart J. 2015; 36(47): 3320-31 | Buccheri D et al. J Thorac Dis. 2016; 8(10): E1150-62