Orchestra BioMed Receives IDE Approval for Virtue SAB Pivotal Trial

April 29, 2025—Orchestra BioMed Holdings, Inc. announced that the FDA has approved an investigational device exemption (IDE) amendment to initiate an updated design of the company’s planned clinical trial of the Virtue SAB (sirolimus angioinfusion balloon) in the treatment of coronary in-stent restenosis.

Data from the prospective, multicenter, randomized Virtue trial will be used to support regulatory approval of the device in the United States, advised the company.

Orchestra BioMed stated that the IDE provides regulatory clearance for the company to commence its United States pivotal trial, which will compare clinical outcomes of the Virtue SAB to the Agent paclitaxel drug-coated balloon (Boston Scientific Corporation), which received FDA approval for a coronary indication in 2024.

As summarized in Orchestra BioMed’s press release, the primary endpoint of the Virtue trial 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. The trial will randomize 740 patients at up to 75 centers in the United States.

With the amended IDE approved by the FDA, initiation of the Virtue trial is targeted for the second half of 2025, advised Orchestra BioMed.

According to the company, Virtue SAB is designed to deliver SirolimusEFR— Orchestra BioMed’s extended-release formulation of sirolimus—through a noncoated microporous angioinfusion balloon that protects the drug in transit to deliver a large liquid dose.