Peripheral Drug-eluting Balloon Earn FDA Breakthrough Device Designation

In addition to the three coronary DCB breakthrough devices mentioned above, two peripheral DCBs also gained breakthrough status in the past year.

Orchestra BioMed, in partnership with Terumo, in September 2019 announced breakthrough device designation for the Virtue Sirolimus-Eluting Balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease.

The Virtue SEB is a novel, first-in-class drug/device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating.

“Virtue SEB’s unique design enables delivery of sustained-release sirolimus during angioplasty without the need for coating or permanent implant. This highly differentiated design makes this product the ideal candidate for Breakthrough Device Designation in BTK peripheral artery disease,” said James P. Zidar, M.D., FACC, FSCAI, clinical professor of medicine, UNC Health Systems, physician-in-chief, Heart & Vascular Corporate. “Currently, there is a significant unmet need in the BTK stenosis treatment landscape. The presence of underlying comorbidities renders many patients unsuitable for bypass surgery. Angioplasty with plain balloons, which has been the default endovascular therapy for years, has a low success rate. Adding a proven anti-restenotic agent like sirolimus has the potential to enhance this treatment approach and drive better patient outcomes.”

Concept Medical was granted breakthrough device designation in August 2019 for its MagicTouch sirolimus-coated DCB for the treatment of PAD in BTK applications.

Article Source: https://www.dicardiology.com/article/recent-developments-drug-coated-balloons