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 BioMed designed Virtue SAB to enable the protected delivery of SirolimusEFR to the artery. The device delivers the proprietary, investigational, extended-release formulation of sirolimus during balloon angioplasty. Its design doesn’t require balloon coating or a permanent implant.