Health
Orchestra BioMed Announces First Patients Enrolled in Virtue® SAB US Pivotal IDE Coronary Trial
Orchestra BioMed’s Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) is the first non-coated drug-eluting balloon system designed to deliver a large liquid dose of proprietary extended-release sirolimus (“SirolimusEFRTM”)The Virtue Trial is the first U.S. investigational device exemption (“IDE”) head-to-head randomized coronary pivotal trial evaluating a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon (AGENT™) Coronary in-stent restenosis (“ISR”), the c
About this update from Orchestra Biomed Holdings, Inc.
[{"type":"image","alt":"Orchestra BioMed Holdings, Inc.","displaySize":"","headline":null,"caption":"Orchestra BioMed Holdings, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":97,"url":"https://media.zenfs.com/en/globenewswire.com/82bb98ef85c6f29f82627c7205a5e888"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/PcUBlKSAoIj3BMZ.626pqg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEzNjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/82bb98ef85c6f29f82627c7205a5e888","width":300,"height":97}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Orchestra BioMed’s Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) is the first non-coated drug-eluting balloon system designed to deliver a large liquid dose of proprietary extended-release sirolimus (“SirolimusEFRTM”)","length":228,"tagName":"p"}]},{"val":[{"type":"text","content":"The Virtue Trial is the first U.S. investigational device exemption (“IDE”) head-to-head randomized coronary pivotal trial evaluating a sirolimus-eluting balloon versus a commercially available paclitaxel-coated balloon (AGENT™) ","length":228,"tagName":"p"}]},{"val":[{"type":"text","content":"Coronary in-stent restenosis (“ISR”), the clinical focus of the Virtue Trial, is a difficult-to-treat and serious complication of coronary stenting that increases the risk of life-threatening heart problems, affecting an estimated 100,000 patients in the U.S. annually","length":268,"tagName":"p"}]},{"val":[{"type":"text","content":"Virtue SAB has FDA Breakthrough Device Designation for the treatment of coronary ISR, as well as for coronary small vessel disease and below-the-knee peripheral artery disease ","length":175,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":899,"olType":false},{"type":"text","content":"NEW HOPE, Pa., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced the first patient enrollments in the Virtue SAB in the Treatment of Coronary ISR Trial (“Virtue Trial”), the Company’s U.S. IDE pivotal trial comparing its highly differentiated Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) to the AGENT paclitaxel-...