Drug Delivery Business

Orchestra BioMed wins FDA IDE for drug-coated balloon study

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Orchestra BioMed logoOrchestra 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.

Get the full story at our sister site, MassDevice.

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.