Orchestra BioMed Enrolls First Patient in Sirolimus AngioInfusion Balloon Trial
Orchestra BioMed (Nasdaq:OBIO) announced the enrollment of the first patient in a study of its Virtue Sirolimus AngioInfusion Balloon (SAB).
The FDA investigational device exemption (IDE) trial compares the Virtue SAB to the Boston Scientific Agent paclitaxel-coated balloon, the only FDA-approved drug-coated balloon (DCB) for coronary indication.
- The trial will enroll up to 740 patients across up to 75 centers in the U.S.
- Initial cases took place at The Christ Hospital Heart & Vascular Institute in Cincinnati, Ohio, and St. Francis Hospital & Heart Center in Roslyn, New York.
The company also continues to advance its atrioventricular interval modulation (AVIM) therapy.
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Author's summary: Orchestra BioMed starts trial for Sirolimus AngioInfusion Balloon.