Medtronic IN.PACT™ AV DCB, now approved for AV fistula maintenance in the US


Watch Andrew Holden (Auckland, New Zealand) present the six-month results of the IN.PACT AV Access trial. The multicentre, prospective, randomised controlled trial shows that treatment with the IN.PACT AV drug-coated balloon (DCB) resulted in 56% fewer target lesion revascularisation procedures when compared to plain balloon percutaneous transluminal angioplasty (PTA). Importantly, the trial did not show a difference in mortality for patients treated with the paclitaxel-coated device when compared with patients treated with PTA at twelve months.

The primary effectiveness endpoint was target lesion primary patency rate through six months, defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or access circuit thrombosis measured six months post-procedure. The trial revealed that six-month target lesion primary patency was 82.2% in the DCB group compared to 59.5% in the PTA group (p<0.001).  In terms of the primary safety endpoint, the 30-day access circuit-related serious adverse event rate was 4.2% in the DCB group and 4.4% in the PTA group.

“The IN.PACT AV trial is the first DCB trial to meet its primary endpoint,” says Holden.

This video is sponsored by Medtronic.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. IN.PACT AV DCB is not available for sale outside the United States of America.
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