NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) has begun enrolling patients in the Virtue SAB in the Treatment of Coronary ISR Trial, a U.S. IDE pivotal study comparing the company’s Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) to AGENT™, the FDA-approved paclitaxel-coated balloon for coronary use. The first cases were completed at The Christ Hospital Heart & Vascular Institute (Cincinnati, OH) and St. Francis Hospital & Heart Center (Roslyn, NY), launching a head-to-head evaluation intended to support U.S. approval.
The trial will randomize 740 patients across up to 75 U.S. centers, targeting completion of enrollment by mid-2027. Its primary endpoint is a 12-month non-inferiority comparison of Target Lesion Failure (cardiac death, nonfatal target vessel MI, and ischemia-driven target lesion revascularization).
Virtue SAB is the first non-coated drug-eluting balloon system designed to deliver a large liquid dose of proprietary extended-release sirolimus (SirolimusEFR™) via a microporous AngioInfusion™ balloon. The approach aims to mitigate coating-related constraints seen with traditional DCBs—such as dosing limits, drug loss in transit, and particulate release—while sustaining therapeutic levels through the healing window. In the multi-center SABRE pilot, Virtue SAB reported 12-month target lesion failure of 2.8%, zero target lesion revascularizations from 12 to 36 months, and 6-month late lumen loss of 0.12 mm.
“Virtue SAB and SirolimusEFR were specifically designed to optimize the dose, delivery, uptake and extended release of sirolimus without the limitations of a drug coating on the balloon surface. A substantial body of clinical evidence from drug-eluting stent studies has established sirolimus and its analogs as the gold-standard drug for promoting vessel healing and preventing restenosis following interventional procedures,” said Jarrod D. Frizzell, MD, MS, FACC, FSCAI, Director of Complex Coronary Therapeutics, Interventional Cardiology, The Christ Hospital Health Network. “The Virtue Trial will allow us to evaluate the performance of this fundamentally different approach to delivering sirolimus, which has shown promising results in a prior pilot clinical study in coronary ISR treatment, in direct comparison to the AGENT paclitaxel-coated balloon.”
“Drug coated balloons offer a promising alternative to drug-eluting stents for the treatment of coronary indications such as coronary ISR. Virtue SAB and SirolimusEFR are designed to go beyond DCBs with the goal of optimizing drug dosing, tissue uptake and extended drug bioavailability at the site of treatment. Our team at St. Francis is excited to play a leadership role in the Virtue Trial which will evaluate this differentiated, non-coated drug-delivery system head-to-head versus the current market leading DCB,” said Allen Jeremias, MD, Director of Interventional Cardiology Research and Associate Director, Cardiac Catheterization Laboratory, St. Francis Hospital & Heart Center.
“We believe the future of arterial disease treatment will be driven by optimized delivery and extended tissue release of therapeutic doses of sirolimus, the proven antiproliferative drug with well-established safety and effectiveness. Balloon surface-coating drug delivery has challenges and limitations, including dosing constraints, drug-loss that requires rapid device navigation, and the release of large embolic particulates. We designed Virtue SAB and its key enabling technology, our proprietary SirolimusEFR, to overcome these limitations and realize the full potential of arterial drug delivery during angioplasty. With the launch of the Virtue Trial, we’re taking a major step toward realizing our vision of improving patient outcomes,” said Darren R. Sherman, President and Chief Operating Officer of Orchestra BioMed.
Coronary in-stent restenosis remains a difficult and clinically significant complication—affecting an estimated 100,000 U.S. patients annually—and Virtue SAB holds FDA Breakthrough Device Designation for ISR, coronary small vessel disease, and below-the-knee peripheral artery disease. Orchestra BioMed estimates the global market opportunity for drug-eluting balloons exceeds $10 billion annually.
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