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# FDA Approves Medtronic In.Pact 018 Balloon Catheter
- URL: https://www.fdaweb.com/fda-approves-medtronic-in-pact-018-balloon-catheter/
- Published: 2022-05-27T12:00:00.000Z
- Updated: 2026-09-14T17:46:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151925

FDA has approved Medtronic’s In.Pact 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, indicated for the interventional treatment of peripheral arterial disease in the superficial femoral and popliteal arteries. The device is intended for de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm with vessel diameters of 4-7 mm, the company says. It will be the only commercially available drug-coated balloon with a 200cm over-the-wire catheter length, providing physicians the option to treat via femoral or radial access, it says.