Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Orchestra BioMed

Orchestra BioMed wins FDA IDE for sirolimus-angioballoon

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Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon. It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) … [Read more...] about Orchestra BioMed wins FDA IDE for sirolimus-angioballoon

Orchestra BioMed wins FDA IDE for drug-coated balloon study

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Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra … [Read more...] about Orchestra BioMed wins FDA IDE for drug-coated balloon study