FDA greenlights Orchestra BioMed to commence Virtue Trial for medical device
Orchestra BioMed, a leading medical device company, is set to compare its innovative Virtue Sirolimus AngioInfusion Balloon (Virtue SAB) with Boston Scientific's AGENT paclitaxel-coated balloon (DCB) in a groundbreaking trial. The Virtue Trial, designed to demonstrate the non-inferiority of the Virtue SAB versus the AGENT DCB, aims to treat coronary in-stent restenosis (ISR) or atherosclerotic artery disease.
The trial's potential advantages lie in the unique design and drug delivery approach of the Virtue SAB. Using sirolimus, an immunosuppressive drug that inhibits neointimal hyperplasia, a key cause of ISR, the device may provide a more effective or longer-lasting inhibition of restenosis compared to paclitaxel. Furthermore, its angioluminal infusion technology could improve drug delivery into the vessel wall, enhancing efficacy while potentially reducing systemic side effects.
The Virtue Trial will randomize 740 patients across up to 75 centers in the U.S. The primary endpoint is a non-inferiority comparison of Target Lesion Failure (TLF) defined as a composite of cardiac death, non-fatal target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 12 months.
Orchestra BioMed's Virtue SAB has already demonstrated promising results in the SABRE pilot study, showing best-in-class clinical results for the treatment of coronary ISR, including a 12-month target lesion failure of 2.8% and a 6-month late lumen loss of 0.12mm.
The Virtue Trial, if successful, could lead to regulatory approvals and commercial partnerships, supporting the adoption of Virtue SAB in coronary applications beyond its current focus on peripheral artery disease. With the FDA's approval of its IDE amendment, Orchestra BioMed is targeting the initiation of the Virtue Trial during the second half of 2025.
The Virtue Trial represents a significant step for Orchestra BioMed, bringing them one step closer to delivering a next-generation solution for atherosclerotic disease. The trial is a landmark event, as it aims to validate if the Virtue SAB's novel sirolimus-based angio-infusion balloon matches or surpasses Boston Scientific’s paclitaxel-coated balloon for coronary ISR treatment.
The Virtue SAB 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 device is the only drug delivery balloon that has demonstrated comparable drug tissue levels to clinically successful drug-eluting stents in large published preclinical studies, without the need to leave a permanent metal implant in the artery.
The superior safety and efficacy of sirolimus over paclitaxel have been highlighted by the performance of drug-eluting stents. According to Dr. Hochman, this is due to their ability to maintain sufficient drug tissue concentration through the critical healing period of approximately 30 days. The Virtue SAB is designed to consistently deliver a large liquid dose of an extended-release formulation of sirolimus to overcome certain limitations of traditional DCBs.
The Virtue SAB's extended-release formulation, SirolimusEFR, enables tissue uptake and the extended release of the required therapeutic levels of sirolimus, the gold-standard drug for preventing arterial restenosis. The Virtue SAB is the only product in development that optimizes both the arterial tissue uptake and retention of sirolimus to achieve pharmacokinetics that match or exceed those of proven 'limus-eluting stents'.
Published meta-analysis involving 76 trials show 'limus-eluting stents have significantly better clinical performance than paclitaxel-eluting stents in terms of target lesion revascularization and major adverse cardiac event. The U.S. market for coronary drug delivery balloons is estimated to be a multibillion-dollar market, based on the significant unmet clinical need, market demand, and established reimbursement.
In conclusion, the Virtue Trial is a significant step forward in the treatment of coronary ISR. By comparing the Virtue SAB to the AGENT DCB, the trial aims to validate the effectiveness and safety of Orchestra BioMed's innovative approach to drug delivery for the treatment of atherosclerotic artery disease.
- The upcoming Virtue Trial is set to explore the effectiveness and safety of sirolimus, a gold-standard drug for preventing arterial restenosis, in the treatment of coronary in-stent restenosis (ISR) or atherosclerotic artery disease, as compared to a paclitaxel-coated balloon from Boston Scientific.
- If successful, the Virtue Trial may lead to regulatory approvals and commercial partnerships, potentially expanding the use of Orchestra BioMed's Virtue Sirolimus AngioInfusion Balloon (Virtue SAB) beyond its current focus on peripheral artery disease, contributing significantly to the health-and-wellness and medical-conditions sector, particularly in improving cardiovascular health.
