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# Orchestra Bio Breakthrough Status for Virtue Balloon
- URL: https://www.fdaweb.com/orchestra-bio-breakthrough-status-for-virtue-balloon/
- Published: 2019-04-24T12:00:00.000Z
- Updated: 2026-09-15T01:22:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143945

FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-eluting Balloon (SEB) for treating coronary in-stent restenosis (ISR). “The unique design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenotic benefits of sirolimus during balloon angioplasty without the potential hazards of a permanent metal implant or a balloon coating that may produce downstream particulates and micro-emboli,” the company says.

The first-in-class drug/device combination product is designed to deliver sustained-release bioabsorbable nanoparticle-encapsulated sirolimus, a proven drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating, Orchestra BioMed says. “Virtue SEB's ability to reliably deliver sirolimus via bioabsorbable particles directly to the artery with an elution profile comparable to commercially available drug-eluting stents has been demonstrated in [extensive non-clinical studies published in a peer-reviewed journal](https://www.globenewswire.com/Tracker?data=enq5khwAbhc3bXwfc6gQH32TkiQ7ksllsMXB0dR-X-wHgsOqCyzGY7ePGAVE7dyBj20SxdYl%5FAzqPAEwXRJBc0pMb7hMBYvNk5Xq0fbvSUtLoIwyQhMWlBChIlp1f9J0Nyhet0u1jXmTpkSQHG2uczrBL9h3tI5hWtvaGAZ6AhNhTeo2VUVKpdSUDXNAlAVmSjEvNFfy0OAprqBz%5FYCgzdDzCRkmmLpmlcgGjVQxtf2DV8M7UuEjAFFUDHbperTd5xjYtjAbRY7hSjyuVGsIxnBqOMDxbuhf53WDlcDIqG39v2s1EHM%5FH-gdjngWYc03wNvof2dOQLMG7%5FyvLn0rrAh54SaINKj8AyllmWPDZIk=&ref=fdaweb.com),” it adds.