FDA grants green light for Virtue Trial initiation by Orchestra BioMed
Orchestra BioMed, a leading medical device company, is gearing up for the initiation of the Virtue Trial during the second half of 2025, following the amendment of the trial's Investigational Device Exemption (IDE) by the FDA. This trial will compare the efficacy and safety of Virtue SAB, Orchestra BioMed's innovative drug-eluting balloon, with Boston Scientific's commercially available AGENT paclitaxel-coated balloon (DCB).
Virtue SAB is a groundbreaking product that optimises both the arterial tissue uptake and retention of sirolimus, the "gold-standard" drug for preventing arterial restenosis, through the critical healing period of approximately 30 days. This is achieved via a microporous AngioInfusion Balloon designed to protect the drug during transit and ensure sustained therapeutic tissue levels.
The potential of Virtue SAB was highlighted in the SABRE pilot study, a multi-center, prospective, independently core-lab adjudicated clinical trial conducted in Europe on 50 patients. The study demonstrated positive three-year clinical outcomes in coronary In-Stent Restenosis (ISR), with 12-month target lesion failure of 2.8% and 6-month late lumen loss of 0.12mm, making Virtue SAB a frontrunner in the treatment of coronary ISR.
The Virtue Trial is a pivotal, randomized, controlled trial that will directly assess clinical outcomes between Virtue SAB and AGENT DCB. The trial, authorised by FDA IDE approval, will randomize 740 patients across up to 75 centers in the U.S. The primary endpoint of the trial is a non-inferiority comparison of Target Lesion Failure (TLF) defined as a composite of cardiac death, nonfatal target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 12 months.
If the results of the Virtue Trial are favourable, they could pave the way for a next-generation solution for atherosclerotic disease. The trial results will also be used to support regulatory approval in the U.S. for Virtue SAB and SirolimusEFR, the extended-release formulation of sirolimus delivered by Virtue SAB.
Orchestra BioMed owns and controls the regulatory filings, clinical operations, and drug and device supplies for the Virtue Trial. The company's belief in the potential market for coronary drug delivery balloons is evident, with a projected multibillion-dollar U.S. market based on the significant unmet clinical need, market demand, and established reimbursement.
In the broader context, published meta-analysis involving 76 trials have shown 'limus-eluting stents have significantly better clinical performance than paclitaxel-eluting stents in terms of target lesion revascularisation and major adverse cardiac event. Dr. Gregg W. Stone, a renowned interventional cardiologist, stated that the superior safety and efficacy of sirolimus over paclitaxel was made clear by the performance of drug-eluting stents, and that Virtue SAB's performance supports this claim.
In summary, the Virtue Trial, currently underway, will provide definitive clinical outcome comparisons between Virtue SAB and AGENT DCB in the treatment of coronary ISR. The results of this trial will clarify if sirolimus-based Virtue SAB offers superior, equivalent, or different clinical benefits compared to paclitaxel-coated AGENT balloons, contributing significantly to the advancement of treatments for atherosclerotic disease.
[References] [1] Orchestra BioMed Press Release, "Orchestra BioMed Announces FDA Approval of IDE Amendment to Initiate Virtue Trial," 2025. [2] Orchestra BioMed Press Release, "Orchestra BioMed Announces Positive Three-Year Clinical Results for Virtue SAB in Coronary ISR," 2023. [5] U.S. Food and Drug Administration, "FDA Breakthrough Device Designation," accessed August 2025, https://www.fda.gov/medical-devices/product-safety-information-for-patients/fda-breakthrough-device-designation.
- The upcoming Virtue Trial, a pivotal study comparing Virtue SAB with AGENT DCB, is exploring health-and-wellness solutions, particularly in cardiovascular health, as it focuses on the treatment of medical-conditions like coronary In-Stent Restenosis.
- If the Virtue Trial results are favorable, the new science behind sirolimus-based Virtue SAB could revolutionize treatments for atherosclerotic disease, potentially transforming the current medical-conditions landscape.
