FDA Expands Indication for Drug-Coated Balloon

The FDA approved Medtronic’s In.Pact Admiral drug-coated balloon for treating long superficial artery lesions in patients with peripheral artery disease.

The approval was based on data from complex lesion imaging cohorts from the company’s global study.

The device can treat lesions up to 360mm and is suitable for treating lesions beyond 180mm, frequently involving in-stent restenosis and chronic total occlusions.