FDA approves Medtronic’s drug-coated balloon in a longer length

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The FDA approved new versions of Medtronic’s IN.PACT Admiral drug-coated balloon on July 13 to treat patients with peripheral artery disease.

The balloon will now be available in longer, 150 mm lengths and in four, five and six mm diameters.

The FDA originally approved the IN.PACT Admiral balloon in December 2014 based on results of a randomized trial that found the clinically driven target lesion revascularization rate was 2.4 percent for patients in the balloon group and 20.6 percent for patients who underwent percutaneous transluminal angioplasty.

Before this week’s approval, the IN.PACT Admiral balloon was available in 40, 60, 80 and 120 mm lengths and in four to seven mm diameters.