FDA grants green light for Orchestra BioMed to commence Virtue Trial
In the ever-evolving world of cardiology, two innovative drug-coated balloons (DCBs) are making waves in the treatment of coronary in-stent restenosis (ISR). The FDA-approved Boston Scientific's AGENT and Orchestra BioMed's Virtue SAB are leading the charge, each offering unique advantages for complex ISR scenarios.
As of mid-2025, AGENT has secured full FDA approval for treating coronary ISR and recently gained Medicare reimbursement, including a New Technology Add-On Payment (NTAP). Clinical trial data from the AGENT IDE trial demonstrate that AGENT is effective not only in single-layer ISR but also in complex cases involving multilayer drug-eluting stents. The benefits are significant, with a reduction in target lesion failure (TLF) compared to plain old balloon angioplasty (POBA), driven by lower rates of target lesion revascularization (TLR) and target-vessel myocardial infarction (MI), with consistent effects across ISR complexity levels.
On the other hand, Virtue SAB is a sirolimus-coated balloon designed for angio-infusion, and while there is limited published information on its performance relative to AGENT, it has been granted FDA Breakthrough Device Designation for the treatment of coronary ISR, coronary small vessel disease, and peripheral artery disease below-the-knee. The Virtue Trial, a prospective, multi-center, randomized trial comparing clinical outcomes of Virtue SAB to AGENT Paclitaxel DCB in the treatment of coronary ISR, is set to provide a more comprehensive comparison.
Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR, through a non-coated microporous AngioInfusion Balloon. This design optimizes both the arterial tissue uptake and retention of sirolimus to achieve pharmacokinetics that match or exceed those of proven 'limus-eluting stents'. The primary endpoint of the Virtue 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.
Dr. Dean J. Kereiakes, a prominent figure in interventional cardiology, has stated that Virtue SAB has the potential to be one of the most compelling technologies in interventional cardiology. Dr. Allen Jeremias, Associate Director of the Cardiac Catheterization Laboratory at St. Francis Hospital & Heart Center, believes that Virtue SAB stands out as the only device with a completely different mechanism of action in the field of DCBs.
Orchestra BioMed Holdings, Inc. has received FDA approval for its Investigational Device Exemption (IDE) to initiate a U.S. pivotal clinical trial for its Virtue SAB. The Virtue Trial, which will randomize 740 patients across up to 75 centers in the U.S., brings Orchestra BioMed one step closer to delivering a next-generation solution for atherosclerotic disease.
Meanwhile, the multi-center SABRE pilot study has already demonstrated best-in-class clinical results for the treatment of coronary ISR with Virtue SAB, including a 12-month target lesion failure of 2.8% and a 6-month late lumen loss of 0.12mm. These results highlight the potential for optimal clinical outcomes with robust sirolimus delivery.
In conclusion, while AGENT currently leads with robust clinical data, regulatory approval, and reimbursement support explicitly for coronary ISR in the United States, the Virtue Trial will provide valuable insights into the performance of Virtue SAB relative to AGENT. The superior safety and efficacy of sirolimus over paclitaxel, as demonstrated by drug-eluting stents, could potentially be showcased by Virtue SAB in the landmark trial.
In the realm of health and wellness, these innovative drug-coated balloons, specifically Boston Scientific's AGENT and Orchestra BioMed's Virtue SAB, are making strides in improving cardiovascular health, particularly in treating medical-conditions such as coronary in-stent restenosis (ISR). Each of these devices offers unique advantages, with AGENT demonstrating significant benefits in reducing target lesion failure and target-vessel myocardial infarction compared to traditional methods, while the Virtue SAB, with its proprieratory formulation of sirolimus, holds the potential to showcase the superior safety and efficacy of sirolimus over paclitaxel in the landmark Virtue Trial.
