Orchestra BioMed’s Pivotal Trial of Virtue SAB for Coronary ISR Begins Enrollment

November 10, 2025—Orchestra BioMed Holdings, Inc. announced that the first patients were enrolled in the United States investigational device exemption (IDE) pivotal study for the company’s Virtue sirolimus angioinfusion balloon (Virtue SAB) in the treatment of coronary in-stent restenosis (ISR). Data from the trial is expected to be used to support regulatory approval of the device in the United States, advised the company.

The multicenter Virtue SAB trial is comparing the Virtue SAB device with the FDA-approved coronary Agent coronary paclitaxel-coated balloon (Boston Scientific). According to Orchestra BioMed, the trial is expected to enroll 740 patients at up to 75 sites across the United States, with completion anticipated in mid-2027. The primary endpoint is a noninferiority comparison of target lesion failure—defined as a composite of cardiac death, nonfatal target vessel myocardial infarction, and ischemia-driven target lesion revascularization—at 12 months.

Dean J. Kereiakes, MD, and Allen Jeremias, MD, serve as Coprincipal Investigators of the trial. The first procedures in the Virtue SAB trial were performed at The Christ Hospital Heart & Vascular Institute in Cincinnati, Ohio, and St. Francis Hospital & Heart Center in Roslyn, New York.

Orchestra BioMed stated that the Virtue SAB delivers its extended-release sirolimus formulation, SirolimusEFR, via a microporous angio-infusion balloon. The system is designed to enable sustained sirolimus delivery through the healing period after angioplasty. In April 2024, the company announced FDA approval of the IDE for the Virtue SAB trial.

In the SABRE pilot study, Virtue SAB demonstrated a 12-month target lesion failure rate of 2.8%, no target lesion revascularizations through 36 months, and a 6-month late lumen loss of 0.12 mm, noted the company.