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Orchestra BioMed Receives FDA Approval of IDE to Initiate U.S. Coronary Pivotal Trial Randomizing First-in-Class Sirolimus-AngioInfusion Balloon, Virtue SAB, Head-to-Head with Paclitaxel-Coated Balloon
Orchestra BioMed’s Virtue® Sirolimus AngioInfusion Balloon™ (“Virtue SAB”) is the only non-coated drug-eluting balloon system under clinical investigation worldwide and has been awarded multiple FDA Breakthrough Device DesignationsThe Virtue Trial will be the first U.S. IDE head-to-head randomized evaluation of a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon (AGENT™) for the treatment of coronary in-stent restenosis (“ISR”)Robust non-inferiority trial is des
About this update from Orchestra Biomed Holdings, Inc.
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