BioMed Orchestra secures FDA clearance to commence Virtue Trial
Orchestra BioMed's Virtue SAB Trial Aims to Revolutionize Coronary ISR Treatment
Orchestra BioMed, a leading medical device company, is set to initiate the Virtue SAB Treatment of Coronary In-Stent Restenosis (ISR) Trial, a landmark study comparing the efficacy of two drug-coated balloon (DCB) technologies for the treatment of coronary ISR.
The trial, which has received FDA clearance, aims to evaluate and compare the safety and efficacy of sirolimus and paclitaxel DCBs in patients with coronary ISR. The primary goal is to identify the better therapeutic option for this common complication of coronary artery disease.
The Virtue SAB trial is a prospective, multi-center, randomized trial comparing clinical outcomes of Virtue SAB, a sirolimus-coated balloon, to AGENT Paclitaxel DCB. The study will be conducted across up to 75 centers in the U.S., and will randomize 740 patients.
The Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR, through a non-coated microporous AngioInfusion Balloon. This unique design enables tissue uptake and extended release of the required therapeutic levels of sirolimus, a "gold-standard" drug for preventing arterial restenosis, through the critical healing period of approximately 30 days.
In the multi-center SABRE pilot study, Virtue SAB demonstrated best-in-class clinical results for the treatment of coronary ISR, including a 12-month Target Lesion Failure (TLF) of 2.8% and a 6-month late lumen loss of 0.12mm.
Notably, Virtue SAB has demonstrated comparable drug tissue levels to clinically successful drug-eluting stents in large published preclinical studies, without the need for a permanent metal implant. This sets Virtue SAB apart as the only device with a completely different mechanism of action in the field of drug-coated balloons.
The Virtue Trial is a significant step towards delivering a next-generation solution for atherosclerotic disease. By comparing sirolimus and paclitaxel DCBs head-to-head, the study could impact future therapeutic strategies and device selection in coronary artery disease management.
Orchestra BioMed is optimistic about the potential of Virtue SAB, with Dr. Allen Jeremias, Associate Director of the Cardiac Catheterization Laboratory at St. Francis Hospital & Heart Center, expressing his belief that Virtue SAB stands out as a promising device. Dr. Dean J. Kereiakes, a prominent figure in interventional cardiology, has also expressed excitement about Virtue SAB's potential to set a new standard of care.
The Virtue Trial is scheduled to begin during the second half of 2025, following the approval of an amendment to Orchestra BioMed's Investigational Device Exemption (IDE) by the FDA. The company is grateful to its clinical collaborators for their work in achieving this important milestone.
With a multibillion-dollar U.S. market for coronary drug delivery balloons due to significant unmet clinical need, market demand, and established reimbursement, Orchestra BioMed is well-positioned to make a significant impact in the field. The successful outcome of the Virtue Trial could pave the way for a new era in the treatment of coronary ISR.
The Virtue SAB Trial, conducted by Orchestra BioMed, focuses on cardiovascular health, as it investigates the efficacy of two drug-coated balloon technologies (sirolimus and paclitaxel DCBs) in treating medical-conditions like coronary In-Stent Restenosis (ISR). This trial is intended to improve health-and-wellness outcomes by identifying the better therapeutic option for this common complication of coronary artery disease.
Statistics from the multi-center SABRE pilot study indicate that Virtue SAB, a sirolimus-coated balloon, demonstrated best-in-class clinical results for the treatment of coronary ISR, potentially making it a 'gold-standard' in science for addressing such medical-conditions in the future.
