Orchestra BioMed gains FDA nod to begin study of Virtue SAB sirolimus balloon


Orchestra BioMed Holdings has been granted US Food and Drug Administration (FDA) investigational device exemption (IDE) approval with conditions to initiate the Virtue ISR-US pivotal study evaluating the efficacy and safety of Virtue SAB for the treatment of patients with coronary in-stent restenosis (ISR).

Virtue SAB is a novel sirolimus-eluting balloon for the treatment of arterial disease that is designed to enable protected delivery of SirolimusEFR, a proprietary, investigational, extended release formulation of sirolimus, to the artery during balloon angioplasty without the need for balloon coating or a permanent implant.

“We believe that Virtue SAB has the potential to address a significant unmet clinical need and improve outcomes for a patient population with suboptimal treatment options,” commented Darren R Sherman, president, chief operating officer and founder of Orchestra BioMed. “In a field currently dominated by paclitaxel-coated balloons, Virtue SAB is the only device that provides protected delivery of extended release sirolimus, the class of drugs used on all currently marketed coronary drug-eluting stents, to the treated artery during angioplasty without the need for a coating or a permanent implant.

“This IDE approval and forthcoming pivotal study reflect our commitment to accelerating innovation through our differentiated, partnership-enabled business model. We look forward to continued collaboration with our partners at Terumo, as well as with the FDA as we work to deliver this highly differentiated, leave-nothing-behind therapy to patients.”

The Virtue SAB IDE approval was supported by three-year follow-up results from the pilot SABRE study, a European multicentre, prospective, independent core lab-adjudicated clinical trial in coronary ISR patients.

The Virtue ISR-US pivotal study is a randomised, prospective, double-blind, multicentre, controlled study of Virtue SAB versus plain old balloon angioplasty (POBA) in the treatment of single-layer coronary ISR.

The study’s primary efficacy and safety endpoint is target lesion failure (TLF) at 12 months. The study will randomise 300 participants 2:1 to Virtue SAB or POBA. In parallel to the randomised arm of the study, Orchestra BioMed plans to enrol a non-randomised arm consisting of 100 participants with double-layer coronary ISR for treatment with Virtue SAB.

Dean J Kereiakes (The Christ Hospital Heart & Vascular Institute, Cincinnati, USA), principal investigator for the Virtue ISR-US study, said: “Virtue SAB’s differentiated design, as well as the encouraging three-year clinical results from the pilot SABRE study make it a potentially compelling treatment option for coronary artery disease indications. The IDE approval of this study represents a crucial step toward generating important data for establishing Virtue SAB’s safety and efficacy and advancing this unique, sirolimus-based leave-nothing-behind therapy to coronary ISR patients.”


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