FDA grants permission for Orchestra BioMed to commence Virtue trial
The Virtue Sirolimus AngioInfusion Balloon (SAB), a promising next-generation treatment for Coronary In-Stent Restenosis (ISR), is making strides in the field of cardiovascular medicine. In 2023, Orchestra BioMed received FDA clearance to initiate a clinical study evaluating the Virtue SAB[3].
This innovative device is designed to deliver sirolimus, a potent anti-proliferative drug, directly into the arterial wall via targeted balloon infusion technology. This approach aims to prevent restenosis (re-narrowing) after stenting in coronary arteries.
As of July 2025, no detailed published clinical trial results or interim efficacy and safety data from the Virtue SAB trial have been reported in publicly available resources or media updates[3][4]. The FDA approval to commence the study is a significant regulatory milestone, but specific outcomes, patient enrollment numbers, or comparative data have not yet been disclosed.
Despite the lack of published results, analysts remain positive on Orchestra BioMed’s prospects. Several have reaffirmed strong buy ratings on the company’s stock, suggesting confidence in its market potential pending clinical validation[1][2].
The Virtue Trial, a prospective, multi-center, randomised trial, will compare clinical outcomes of the Virtue SAB to AGENT Paclitaxel DCB in the treatment of coronary ISR. The trial will randomize 740 patients across up to 75 centers in the U.S.
Dr. Allen Jeremias, another interventional cardiologist, anticipates continued momentum for drug-coated balloons and is eager to see how Virtue SAB performs in a head-to-head trial against a paclitaxel-coated balloon.
Orchestra BioMed's Virtue SAB has received FDA Breakthrough Device Designation for the treatment of coronary ISR, coronary small vessel disease, and peripheral artery disease below-the-knee. Notably, the Virtue SAB does not require the need to leave a permanent metal implant in the artery.
In the SABRE pilot study, Virtue SAB demonstrated best-in-class clinical results for the treatment of coronary ISR, including a 12-month target lesion failure of 2.8% and 6-month late lumen loss of 0.12mm[5].
Dr. Dean J. Kereiakes, a prominent figure in interventional cardiology, believes Virtue SAB has the potential to set a new standard of care. The company is grateful to its clinical collaborators for their work in achieving this important milestone.
Virtue SAB is the only product in development that optimizes both arterial tissue uptake and retention of sirolimus to achieve pharmacokinetics that match or exceed those of proven 'limus-eluting stents'. It is also the only drug delivery balloon that has demonstrated comparable drug tissue levels to clinically successful drug-eluting stents in large published preclinical studies[6].
With the amended IDE approved by the FDA, Orchestra BioMed is currently targeting initiation of the Virtue Trial during the second half of 2025[2]. The company believes there is a multibillion-dollar U.S. market for coronary drug delivery balloons due to significant unmet clinical need, market demand, and established reimbursement.
Mr. Hochman, CEO of Orchestra BioMed, expressed excitement to showcase the full potential of Virtue SAB in the landmark trial[7]. As the trial progresses, we eagerly await further clinical outcome data to assess the potential of this next-generation solution for atherosclerotic disease.
References: 1. Seeking Alpha 2. Yahoo Finance 3. Orchestra BioMed Press Release 4. Cardiovascular Business 5. Orchestra BioMed Press Release 6. Orchestra BioMed Press Release 7. Orchestra BioMed Press Release
- The Virtue SAB, when compared to AGENT Paclitaxel DCB, is being evaluated in a multi-center, randomized trial called The Virtue Trial for the treatment of Coronary In-Stent Restenosis (ISR), which is a medical-condition related to cardiovascular-health and health-and-wellness.
- The Virtue SAB is the only product in development that optimizes both arterial tissue uptake and retention of sirolimus, a potent anti-proliferative drug, to achieve pharmacokinetics that match or exceed those of proven 'limus-eluting stents', showcasing its significant potential for the treatment of cardiovascular-health conditions like coronary ISR.
