NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has received FDA approval to move forward with its Virtue Trial, a pivotal clinical study designed to evaluate its next-generation Sirolimus-AngioInfusion Balloon (Virtue SAB) against the Boston Scientific AGENT paclitaxel-coated balloon. This trial represents a crucial step toward regulatory approval of a technology that holds promise for transforming the treatment of coronary in-stent restenosis (ISR).
Virtue SAB, which has already received FDA Breakthrough Device Designation, employs a unique sirolimus delivery mechanism through its non-coated AngioInfusion™ Balloon. The proprietary extended-release formulation, known as SirolimusEFR™, ensures consistent high-dose drug delivery directly to the arterial tissue, overcoming common drug-coated balloon limitations like drug loss during transit and inconsistent dosing. According to Orchestra BioMed, this innovation could rival the efficacy of sirolimus-eluting stents without the need for permanent implants.
Dr. Dean J. Kereiakes, Co-Principal Investigator of the Virtue Trial, highlighted the significance of the device. “Virtue SAB optimizes tissue uptake and retention of sirolimus, achieving pharmacokinetics comparable to clinically proven drug-eluting stents. It has the potential to set a new standard of care in interventional cardiology.”
The Virtue Trial will bring together 740 participants across 75 U.S. centers and compare outcomes of Virtue SAB to AGENT DCB in coronary ISR treatment. The primary endpoint will assess target lesion failure at 12 months, measuring indicators like cardiac death, nonfatal myocardial infarction, and lesion revascularization. Orchestra BioMed plans to initiate the study in the second half of 2025, signaling progress toward addressing a condition that affects more than 325,000 patients annually worldwide.
David Hochman, Chairman and CEO of Orchestra BioMed, emphasized the significance of a head-to-head trial with the AGENT paclitaxel-coated balloon. “We believe Virtue SAB’s ability to achieve sustained therapeutic tissue levels through the entire critical healing period will demonstrate a differentiated and superior approach to treating coronary ISR.”
Coronary ISR remains a challenging complication of stenting, raising the risk of severe heart conditions if untreated. Virtue SAB’s sirolimus delivery platform may help prevent re-narrowing of arteries while also mitigating limitations of existing technologies.
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