Orchestra BioMed Granted IDE Approval for Virtue ISR-US Pivotal Study of Virtue SAB Device

August 8, 2023—Orchestra BioMed Holdings, Inc. announced that the FDA granted investigational device exemption (IDE) approval with conditions to initiate the Virtue ISR-US pivotal study evaluating the efficacy and safety of the company’s Virtue sirolimus angio-infusion balloon (SAB) for the treatment of patients with coronary in-stent restenosis (ISR).

The company is permitted to begin enrollment upon completion of standard clinical trial initiation activities including clinical center Institutional Review Board approvals. The conditional approval also requires the company to submit additional information to the FDA. Virtue ISR-US pivotal study is currently expected to start before the end of 2023, stated Orchestra BioMed.

Virtue SAB is designed to enable protected delivery of SirolimusEFR to the artery during balloon angioplasty without the need for balloon coating or a permanent implant. SirolimusEFR is the company’s investigational, extended-release formulation of sirolimus.

According to Orchestra BioMed, the Virtue ISR-US pivotal study is a randomized, prospective, double-blind, multicenter, 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 at 12 months.

The study will randomize approximately 300 participants 2:1 to Virtue SAB or POBA. In parallel to the randomized arm of the study, Orchestra BioMed plans to enroll a nonrandomized arm composed of approximately 100 participants with double-layer coronary ISR for treatment with Virtue SAB.

Orchestra BioMed noted that the IDE approval was supported by 3-year follow-up results from the pilot SABRE study, a European multicenter, prospective, independent core lab-adjudicated clinical trial of the Virtue SAB in coronary ISR patients.

Dean J. Kereiakes, MD, is the Principal Investigator for the Virtue ISR-US study. Dr. Kereiakes is President of The Christ Hospital Heart & Vascular Institute and Medical Director of The Christ Hospital Research Institute in Cincinnati, Ohio, and Professor of Clinical Medicine at The Ohio State University in Columbus, Ohio.

“Virtue SAB’s differentiated design, as well as the encouraging 3-year clinical results from the pilot SABRE study make it a potentially compelling treatment option for coronary artery disease indications,” commented Dr. Kereiakes in Orchestra BioMed’s press release. “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.”

In 2019, the company announced that the investigational Virtue SAB device was granted Breakthrough Device designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease, and peripheral artery disease below-the-knee.

Orchestra BioMed advised it has a strategic partnership with Japan-based Terumo, as well as Terumo Medical Corporation, its United States subsidiary, to collaborate on the global development and commercialization of Virtue SAB in coronary and peripheral vascular indications.