Orchestra BioMed Granted FDA IDE Nod for Virtue ISR-US Study

Orchestra BioMed has gained U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval to begin its Virtue ISR-US pivotal study.
 
The study will assess the safety and efficacy of the Virtue sirolimus AngioInfusion balloon (SAB) to treat coronary in-stent restenosis (ISR). Virtue SAB is an AngioInfusion to treat artery disease and was designed to allow protective delivery of SirolimusEFR—a proprietary, investigational, extended-release sirolimus formulation—to the artery during balloon angioplasty without needing a balloon coating or 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. 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,” Darren R. Sherman, president, chief operating officer, and founder of Orchestra BioMed, told the press. “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.”
 
Virtue SAB IDE’s approval was supported by three-year follow-up results from the pilot SABRE study, a European clinical trial in coronary ISR patients. The Virtue ISR-US pivotal study is a controlled study of Virtue SAB vs. Plain Old Balloon Angioplasty (POBA) to treat single-layer coronary ISR.
 
The study’s primary efficacy and safety endpoint is target lesion failure (TLF) at 12 months. The study will randomize about 300 participants 2:1 to Virtue SAB or POBA. Orchestra BioMed plans to enroll a non-randomized arm composed of about 100 participants with double-layer coronary ISR for treatment with Virtue SAB.
 
Dean J. Kereiakes, M.D., FACC, MSCAI, president of The Christ Hospital Heart & Vascular Institute, Medical Director of The Christ Hospital Research Institute, Professor of Clinical Medicine at The Ohio State University, and principal investigator for Virtue ISR-US commented, “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.”