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DCB catheter receives FDA breakthrough device designation
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B. Braun Interventional Systems announced that a drug-coated balloon catheter for percutaneous transluminal coronary angioplasty has received a breakthrough device designation from the FDA for the treatment of patients with coronary in-stent restenosis.
The DCB catheter (SeQuent Please ReX) is the latest generation catheter from the company, according to a press release. This line of DBCs underwent 10 years of clinical study evaluations for several indications including in-stent restenosis for drug-eluting and bare metal stents and initial stenosis in de novo lesions.
“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,” Peter Flosdorf, engineering manager at B. Braun Interventional Systems, said in the release. “This device is the gold standard coronary DCB based on the available clinical evidence.”
The breakthrough device designation from the FDA is granted to devices that can offer more effective treatment for patients with life-threatening diseases, according to the release. This allows the device to proceed faster through the development, assessment and review process with standards typically used for premarket approval, 510(k) clearance and de novo marketing authorization.
Disclosure: Flosdorf is an employee of B. Braun Interventional Systems.