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# In.Pact Drug Coated Balloon OK’d for Complex Lesions
- URL: https://www.fdaweb.com/in-pact-drug-coated-balloon-okd-for-complex-lesions/
- Published: 2018-04-23T12:00:00.000Z
- Updated: 2026-09-15T00:00:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141276

FDA has approved a Medtronic PMA for In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions up to 360mm in patients with peripheral artery disease. The device’s approval was based on clinical data from the In.Pact Global Study in-stent restenosis and chronic total occlusion patient groups. The data showed “maintenance of strong clinical outcomes, including a high primary patency rate and limited need for reintervention in patients exhibiting these complex, long lesions,” the company says. “Complex lesions, including those over 150mm, remain a significant treatment challenge for physicians.”