Virtue AVF

Orchestra BioMed, in partnership with Terumo, has secured Breakthrough Device Designation by the FDA for its Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee peripheral arterial disease. A press release reports that currently approved therapeutic options for peripheral arterial disease are limited and have been shown to be marginally effective, leaving substantial unmet need for more effective treatment options for below-the-knee atherosclerosis.

The press release adds that 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.

James P Zidar (UNC Health Systems, Chapel Hill, USA) says: “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 below-the-knee peripheral arterial disease. Currently, there is a significant unmet need in the below-the-knee 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.”

Darren R Sherman, president, chief operating officer and co-founder of Orchestra BioMed, states: “Our team is grateful that the FDA has recognised the potential value Virtue SEB can provide patients and physicians by granting this second Breakthrough Device Designation for an important arterial therapeutic indication. This designation will be critical as we continue to work with Terumo to accelerate Virtue SEB’s global clinical and regulatory programme in both coronary and peripheral indications. In below-the-knee disease, treatment with Virtue SEB has the potential to improve long-term outcomes and reduce periprocedural complications which can extend hospital stay and increase cost of treatment.”