Orchestra BioMed Announces FDA Breakthrough Device Designation for Virtue Sirolimus-Eluting Balloon for Treatment of Below-the-Knee Peripheral Artery Disease

  • First and only non-coated sirolimus-eluting angioplasty balloon system to receive Breakthrough Device designation for below-the-knee disease 
  • Follows Breakthrough Device designation for Virtue Sirolimus-Eluting Balloon in coronary in-stent restenosis granted in Q2  2019

NEW HOPE, Pa., Sept. 17, 2019 — Orchestra BioMed, Inc., a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, in partnership with Terumo Corporation, announced the Company has secured Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its Virtue Sirolimus-Eluting Balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease.

Peripheral artery disease (PAD) affects approximately 8.5 million people in the U.S and is growing dramatically in the elderly population.1 BTK (infrapopliteal) atherosclerosis is the most common cause of critical limb ischemia (CLI), which is associated with a high rate of amputations and poor survival outcomes.2 The treatment of BTK atherosclerotic disease is complex as lesions in these small diameter arteries tend to be diffuse, long and often involve calcification. Currently approved therapeutic options are limited and have been shown to be marginally effective, leaving substantial unmet need for more effective treatment options for BTK atherosclerosis.

 “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, MD, 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.”

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. Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. Manufacturers are then able to offer patients and healthcare providers quicker access to new medical devices by expediting the development, assessment, and review process. 

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

About Virtue® SEB 

Virtue SEB is a novel, first-in-class drug/device combination product that delivers sustained-release bioabsorbable encapsulated sirolimus, a proven drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating. Virtue SEB’s ability to reliably deliver sirolimus via bioabsorbable sub-micron particles with a drug elution profile comparable to commercially available drug-eluting stents has been demonstrated in extensive preclinical studies published in a peer-reviewed journal.3  Virtue SEB is the first and only non-coated sirolimus-eluting angioplasty balloon system to receive FDA Breakthrough Designation for below-the-knee stenosis as well as for coronary in-stent restenosis (ISR), another challenging indication for which the product has shown promising 3-year core-lab adjudicated efficacy and safety clinical results in the SABRE trial. Orchestra BioMed and Terumo plan to execute a global clinical program to gain regulatory approval for commercial sale of Virtue SEB in multiple markets and indications including coronary ISR and below-the-knee stenosis.