Medtronic snags breakthrough designation for below-the-knee drug-coated balloon

Medtronic (NYSE:MDT) has secured a breakthrough designation from the FDA for a version of its drug-coated balloon aimed at unblocking arteries below the knee, following years of development.

The In.Pact BTK catheter is slated for an international, randomized pivotal trial that plans to enroll about 400 participants with peripheral artery disease in the lower legs, and who face risks of major amputation or death from chronic limb-threatening ischemia, or CLTI.

The company said it is currently working with regulators to finalize the study design within the next few months.

Read full article: https://www.massdevice.com/medtronic-breakthrough-designation-below-the-knee-drug-coated-balloon/