Orchestra BioMed’s Virtue SEB Receives FDA Breakthrough Device Designation for BTK Treatment of PAD


September 17, 2019—Orchestra BioMed, Inc., in partnership with Terumo Corporation, announced that the FDA has granted Breakthrough Device designation for its Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease.

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 BTK stenosis and coronary in-stent restenosis (ISR). In April 2019, the company announced that the Virtue SEB had received the designation for coronary ISR.

According to the company, the Virtue SEB delivers a sustained-release bioabsorbable-encapsulated sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. The company advised that in published preclinical studies, Virtue SEB has demonstrated the ability to reliably deliver sirolimus via bioabsorbable submicron particles with a drug-elution profile comparable to commercially available drug-eluting stents.

In Orchestra BioMed’s announcement, James P. Zidar, MD, commented, “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.

Dr. Zidar continued, “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 antirestenotic agent like sirolimus has the potential to enhance this treatment approach and drive better patient outcomes.” Dr. Zidar is Clinical Professor of Medicine at UNC Health Systems in Chapel Hill, North Carolina.

Orchestra BioMed noted that for the coronary ISR indication, the Virtue SEB device has shown promising 3-year core-lab–adjudicated efficacy and safety clinical results in the SABRE trial, which was presented by Juan Granada, MD, at TCT 2018, the Transcatheter Cardiovascular Therapeutics conference held September 21–25 in San Diego, California.

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 health care providers quicker access to new medical devices by expediting the development, assessment, and review process, stated Orchestra BioMed.


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