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# Orchestra BioMed’s Trial OK’d on Sirolimus Balloon
- URL: https://www.fdaweb.com/orchestra-biomeds-trial-okd-on-sirolimus-balloon/
- Published: 2025-05-08T12:00:00.000Z
- Updated: 2026-09-14T15:11:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159142

FDA has given Orchestra BioMed the green light to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusion Balloon (Virtue SAB) for treating coronary in-stent restenosis. The agency approved a study design amendment allowing a head-to-head trial comparing Virtue SAB to the only FDA-approved coronary drug-coated balloon (DCB), Boston Scientific’s Agent paclitaxel-coated balloon, according to Orchestra.

The Virtue Trial aims to generate the clinical data needed for regulatory approval in the U.S. and will enroll up to 740 patients across 75 sites beginning in the second half of 2025, the company says. The primary goal is to demonstrate non-inferiority in reducing target lesion failure compared to the Agent device.

The company says that what sets Virtue SAB apart is its unique delivery method. Unlike traditional DCBs that rely on surface coatings, Virtue SAB uses a non-coated microporous AngioInfusion Balloon to administer SirolimusEFR, a proprietary extended-release formulation of sirolimus, it explains. This method is designed to enable a large, consistent liquid dose to reach arterial tissue and sustain therapeutic drug levels through the crucial 30-day healing period.