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Explain this story: Medtronic drug-coated balloon gets FDA breakthrough status
Medtronic has received FDA breakthrough device designation for its drug-coated balloon catheter designed to treat peripheral artery disease (PAD) below the knee. This is a significant development as current drug-coated balloons are not indicated for use in this area, which is historically difficult to treat and can lead to amputation. Medtronic plans a randomized pivotal trial with approximately 400 patients to study the effectiveness of its IN.PACT BTK paclitaxel-coated device.
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Medtronic has received FDA breakthrough device designation for its drug-coated balloon catheter designed to treat peripheral artery disease (PAD) below the knee. This is a significant development as current drug-coated balloons are not indicated for use in this area, which is historically difficult to treat and can lead to amputation. Medtronic plans a randomized pivotal trial with approximately 400 patients to study the effectiveness of its IN.PACT BTK paclitaxel-coated device.
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Published Oct 1, 2026, 12:10 ET · on this site +1h 7m