Home » Regulation » News

News

FDA grants breakthrough device designation for B. Braun’s drug-coated PTCA balloon catheter

RegulationApprovals

SeQuent Please ReX is the latest-generation coronary drug-coated balloon catheter developed by B. Braun

USFDAdevice

The US FDA’s Center for Devices and Radiological Health (Image credit: The US Food and Drug Administration)

B.Braun Interventional Systems (BIS) has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its SeQuent Please ReX drug-coated PTCA balloon catheter to treat coronary in-stent restenosis (ISR).

SeQuent Please ReX is B. Braun’s latest-generation coronary drug-coated balloon (DCB) catheter.

Clinical study evaluations on SeQuent Please drug-coated PTCA catheters

The company conducted extensive clinical study evaluations on SeQuent Please drug-coated PTCA catheters for ten years and published data in peer-reviewed articles.

The studies have assessed the use of catheters in different 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.

According to the company, in-stent restenosis is the gradual re-narrowing of a coronary artery following stent implantation and remains a challenge in the interventional community.

Braun Interventional Systems engineering manager Peter Flosdorf said: “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.

“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.”

FDA will provide breakthrough device designation to certain medical devices and device-led combination products, which provided efficient treatment for life-threatening or irreversibly debilitating diseases.

The breakthrough device designation will protect the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorisation.

Braun Interventional Systems, part of the B. Braun Group of Companies, provides interventional solutions to the patients.

In July 2018, B. Braun Medical agreed to acquire the bloodlines business operated under the Medisystems name by medical technology company NxStage Medical.