FDA approves the IN.PACT balloon to treat in-stent restenosis

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The FDA approved Medtronic’s IN.PACT Admiral drug-coated balloon Sept. 13 to treat in-stent restenosis in patients with peripheral artery disease.

Medtronic said in a news release that the IN.PACT Admiral was the first drug-coated balloon that the FDA approved to treat in-stent restenosis, which the company said occurs in nearly 40 percent of stents placed in the superficial femoral artery.

The approval was based on results of real-world data from the IN.PACT global study. The one-year primary patency rate for patients with complex in-stent restenosis was 88.7 percent, while the clinically driven target revascularization rate was 7.3 percent. The mean length of lesions was 17.2 cm, and 34 percent were occluded in-stent restenosis lesions.

The FDA approved the IN.PACT Admiral in December 2014 to treat peripheral artery disease. In July, the FDA expanded the drug-coated balloon’s indication to include longer, 150 mm lengths and in four, five and six mm diameters.