Orchestra BioMed, a biomedical innovation company, in partnership with Terumo, a Japanese medical device manufacturer, has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for its Virtue Sirolimus-Eluting Balloon (SEB).

Orchestra BioMed is engaged in providing high-impact solutions for procedure-based medicine and its SEB is used in the treatment of below-the-knee (BTK) peripheral artery disease.

Orchestra BioMed president, chief operating officer and co-founder Darren R Sherman said: “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.

“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 is used in treating BTK stenosis and coronary in-stent restenosis (ISR)

Virtue SEB is an advanced combination product designed to deliver sustained-release bioabsorbable encapsulated restenosis drug sirolimus, directly to the artery during balloon angioplasty avoiding the need for a coating.

According to preclinical studies published in peer-reviewed journal, Virtue SEB is capable of reliably delivering sirolimus through bioabsorbable sub-micron particles compared to commercially available drug-eluting stents.

In addition, Virtue SEB marks the first and only non-coated sirolimus-eluting angioplasty balloon system to secure FDA Breakthrough Designation for BTK stenosis and coronary ISR.

The 3 year core-lab adjudicated SABRE clinical trial evaluating safety and efficacy of Virtue SEB has showed positive results for challenging indication coronary ISR.

Orchestra BioMed and Terumo intend to conduct an international clinical program to obtain regulatory approval for commercial sale of Virtue SEB in multiple markets and indications including coronary ISR and below-the-knee stenosis.

UNC Health Systems heart & vascular corporate physician-in-chief and clinical professor of medicine James P Zidar said: “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. Currently, there is a significant unmet need in the BTK stenosis treatment landscape.