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# FDA Breakthrough Status for Sirolimus-Eluting Balloon
- URL: https://www.fdaweb.com/fda-breakthrough-status-for-sirolimus-eluting-balloon/
- Published: 2019-09-18T12:00:00.000Z
- Updated: 2026-09-15T01:50:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145039

FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-Eluting Balloon for treating below-the-knee peripheral artery disease. The device is designed to deliver sustained-release sirolimus during angioplasty without the need for coating or a permanent implant. “Angioplasty with plain balloons, which has been the default endovascular therapy for years, has a low success rate,” the company says. “Adding a proven anti-restenotic agent like sirolimus has the potential to enhance this treatment approach and drive better patient outcomes.”