Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease.
The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release.
The New Hope, Pa.-based company’s Virtue SEB is designed to deliver sustained-release, bioabsorbable, encapsulated sirolimus to the artery during balloon angioplasty without a need for coating. The Virtue SEB also received breakthrough designation in April for coronary in-stent restenosis.
“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,” added Heart & Vascular Corporate physician-in-chief Dr. James Zidar. “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.”