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Orchestra BioMed wins breakthrough nod for Virtue SEB

Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue […]

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.

Orchestra BioMed, in partnership with Terumo (OTC:TRUMY;TYO:4543), plans to execute a global clinical program to obtain regulatory approval for the commercialization of Virtue SEB in multiple markets and indications, including coronary ISR and below-the-knee stenosis.
“Our team is grateful that the FDA has recognized the potential value Virtue SEB can provide patients and physicians by granting this second breakthrough device designation for an important arterial therapeutic indication,” said Orchestra BioMed co-founder, president & chief operating officer Darren Sherman said in prepared remarks. “This designation will be critical as we continue to work with Terumo to accelerate Virtue SEB’s global clinical and regulatory program in both coronary and peripheral indications. In BTK 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.”

“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.”
Original Article: (https://www.massdevice.com/orchestra-biomed-wins-breakthrough-nod-for-virtue-seb/)

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