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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.
500216 ©2019 Medtronic. All rights reserved. Medtronic, Medtronic logo are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. For global distribution.
12/2019. Medtronic: https://www.medtronic.com

Holden, Andrew

Holden, Andrew

Andrew Holden is the director of interventional radiology at Auckland Regional Public Health Service and associate professor of Radiology at Auckland University School of Medicine in Auckland, New Zealand. He has been involved in the investigation of several endovascular devices for the treatment of abdominal aortic aneurysms and peripheral arterial disease

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