FDA grants approval for Virtue Trial initiation by Orchestra BioMed
The Virtue Trial, a groundbreaking clinical study, is set to compare the performance of Orchestra BioMed's Virtue SAB balloon catheter with Boston Scientific's AGENT paclitaxel-coated balloon in the treatment of coronary in-stent restenosis (ISR).
The Virtue SAB employs an innovative extended-release sirolimus formulation (SirolimusEFR™) delivered via a non-coated microporous AngioInfusion™ Balloon. This technology aims to provide a high liquid dose of sirolimus, maintaining therapeutic tissue concentrations over a critical healing period (~30 days), thereby overcoming limitations of conventional drug-coated balloons (DCBs).
In contrast, the AGENT balloon utilizes paclitaxel with a polymer-based coating. While both drugs inhibit restenosis, sirolimus, known as the "gold-standard" for preventing arterial restenosis, has shown potential for better safety and durability profiles in recent studies.
The Virtue Trial, a prospective, multi-center, randomized trial, will randomize 740 patients across up to 75 centers in the U.S. Its primary endpoint 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.
The Virtue SAB has demonstrated comparable drug tissue levels to clinically successful drug-eluting stents in large published preclinical studies. In the multi-center SABRE pilot study, Virtue SAB demonstrated best-in-class clinical results for the treatment of coronary ISR, including 12-month target lesion failure of 2.8% and 6-month late lumen loss of 0.12mm.
Notably, Virtue SAB has received Breakthrough Device Designation by the FDA for coronary ISR, small vessel disease, and peripheral artery disease below-the-knee, highlighting regulatory recognition of its innovative profile. On the other hand, Boston Scientific's AGENT balloon faces ongoing scrutiny related to paclitaxel safety concerns in peripheral artery disease.
Interventional cardiologists, such as Dr. Allen Jeremias and Dr. Dean J. Kereiakes, have expressed optimism about Virtue SAB, with Dr. Kereiakes stating that it has the potential to be one of the most compelling technologies in interventional cardiology.
Orchestra BioMed 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. With the amended IDE approved by the FDA, Orchestra BioMed is currently targeting initiation of the Virtue Trial during the second half of 2025.
The Virtue Trial is a landmark trial aiming to showcase the full potential of Virtue SAB in treating coronary ISR, potentially delivering a next-generation solution for atherosclerotic disease.
Science and medical-conditions surrounding cardiovascular health and health-and-wellness are at the forefront of the Virtue Trial, which is comparing the performance of Orchestra BioMed's Virtue SAB balloon catheter, a device employing an innovative extended-release sirolimus formulation, with Boston Scientific's AGENT paclitaxel-coated balloon for treating coronary in-stent restenosis. This trial aims to assess the safety and efficacy of the Virtue SAB against Target Lesion Failure, a composite of cardiac death, nonfatal target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 12 months.
