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BioWorld - Tuesday, December 16, 2025
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Home » Medtronic’s In.Pact AV DCB wins FDA nod
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Medtronic’s In.Pact AV DCB wins FDA nod

Nov. 21, 2019
By Meg Bryant
The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.
BioWorld MedTech Regulatory Cardiovascular Dialysis

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