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# Medtronic Drug-coated Balloon OK'd for In-stent Restinosis
- URL: https://www.fdaweb.com/medtronic-drug-coated-balloon-okd-for-in-stent-restinosis/
- Published: 2016-09-15T12:00:00.000Z
- Updated: 2026-09-14T21:32:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136812

FDA has approved a Medtronic PMA for the IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with peripheral artery disease. This is the first drug-coated balloon approved to treat in-stent restenosis in the U.S. Approval was based on data from the IN.PACT Global Study where the coated balloon was compared to a standard percutaneous balloon angioplasty control, the company says. The new balloon’s primary mode of action is physical dilatation of the vessel lumen by percutaneous balloon angioplasty, and the use of paclitaxel on the device is intended to prevent artery narrowing by minimizing scar tissue formation, it says.