On Monday, October 27, 2025, Orchestra BioMed Holdings, Inc. announced that it has enrolled its first patients in the Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) U.S. IDE pivotal trial, the Treatment of Coronary In‑Stent Restenosis (ISR) Trial. The initial cases were successfully completed by teams at The Christ Hospital Heart & Vascular Institute in Cincinnati, Ohio, and St. Francis Hospital & Heart Center in Roslyn, New York, marking the official launch of the study.
The Virtue Trial is a randomized, head‑to‑head comparison of Virtue SAB against the AGENT paclitaxel‑coated balloon, the only drug‑coated balloon currently FDA‑approved for a coronary indication. The study will enroll 740 patients at up to 75 U.S. centers and will evaluate non‑inferiority of target lesion failure—defined as a composite of cardiac death, non‑fatal target vessel myocardial infarction, and ischemia‑driven target lesion revascularization—at 12 months.
Virtue SAB has already received FDA Breakthrough Device Designation for coronary ISR, coronary small vessel disease, and below‑the‑knee peripheral artery disease, underscoring its differentiated technology and the potential for accelerated regulatory review. The initiation of the pivotal trial is a critical step toward obtaining U.S. market approval and will provide the clinical evidence needed to support commercialization and partnership revenue streams with its strategic partner, Terumo Corporation.
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