FDA News

Sirolimus-eluting balloon given breakthrough device designation

Orchestra BioMed Inc., in partnership with Terumo Corporation, announced its sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease, has received breakthrough device designation from the FDA.

The sirolimus-eluting balloon (Virtue) is a first-in-class drug and device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating, according to a press release from Orchestra Biomed.

As Healio previously reported, a version of the balloon for treatment of coronary in-stent restenosis received breakthrough device designation in April.

The development comes during a time when paclitaxel-coated devices to treat PAD are under scrutiny for a long-term mortality signal detected in a summary-level meta-analysis and confirmed in an FDA analysis.

"This designation will be critical as we continue to work with Terumo to accelerate Virtue’s global clinical and regulatory program in both coronary and peripheral indications,” Darren R. Sherman, president, chief operating officer and co-founder of Orchestra BioMed, said in a press release. “In below-the-knee disease, treatment with Virtue sirolimus-eluting balloon has the potential to improve long-term outcomes and reduce periprocedural complications which can extend hospital stay and increase cost of treatment."

"Currently, there is a significant unmet need in the below-the-knee stenosis treatment landscape,” James P. Zidar, MD, FACC, FSCAI, clinical professor of medicine, UNC Health Systems and physician-in-chief, Heart & Vascular Corporate, said in the release. “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."

Disclosures: Sherman is an employee of Orchestra Biomed. Zidar reports he has served as a consultant for Abbott Vascular, Medtronic and Siemens and is on the advisory board for Abbott Vascular and Medtronic.

Orchestra BioMed Inc., in partnership with Terumo Corporation, announced its sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease, has received breakthrough device designation from the FDA.

The sirolimus-eluting balloon (Virtue) is a first-in-class drug and device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating, according to a press release from Orchestra Biomed.

As Healio previously reported, a version of the balloon for treatment of coronary in-stent restenosis received breakthrough device designation in April.

The development comes during a time when paclitaxel-coated devices to treat PAD are under scrutiny for a long-term mortality signal detected in a summary-level meta-analysis and confirmed in an FDA analysis.

"This designation will be critical as we continue to work with Terumo to accelerate Virtue’s global clinical and regulatory program in both coronary and peripheral indications,” Darren R. Sherman, president, chief operating officer and co-founder of Orchestra BioMed, said in a press release. “In below-the-knee disease, treatment with Virtue sirolimus-eluting balloon has the potential to improve long-term outcomes and reduce periprocedural complications which can extend hospital stay and increase cost of treatment."

"Currently, there is a significant unmet need in the below-the-knee stenosis treatment landscape,” James P. Zidar, MD, FACC, FSCAI, clinical professor of medicine, UNC Health Systems and physician-in-chief, Heart & Vascular Corporate, said in the release. “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."

Disclosures: Sherman is an employee of Orchestra Biomed. Zidar reports he has served as a consultant for Abbott Vascular, Medtronic and Siemens and is on the advisory board for Abbott Vascular and Medtronic.