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.”
