Study Published in The New England Journal of Medicine Demonstrates Patients Experience Fewer Disruptions to Dialysis Therapy When Treated with Medtronic Drug-Coated Balloon - Seite 2

The IN.PACT AV Access study is a randomized controlled trial (RCT), which has enrolled 330 subjects at 29 sites in United States, Japan, and New Zealand. Notably, the IN.PACT AV DCB is the first and only approved DCB for the treatment of failing AV access to meet both its primary safety and effectiveness endpoints. Through six months, the rate of target lesion primary patency was substantially higher in participants treated in the IN.PACT AV DCB group compared to those in the PTA control group (82.2% vs. 59.5% (p<0.001)). Kaplan-Meier estimates for this dataset indicate:

• 86.1% primary patency rate in the IN.PACT AV DCB group compared to 68.9% in the PTA control group (log-rank p<0.001) of the target lesion at 180 days. 
• 81.4% primary patency rate in the IN.PACT AV DCB group compared to 59.0% in the PTA control group (log-rank p<0.001) through 210 days.

Furthermore, patients treated with IN.PACT AV DCB required 56% fewer reinterventions to maintain lesion patency as compared to those treated with standard PTA through six months.

For its primary safety endpoint, the IN.PACT AV DCB group showed non-inferiority versus the PTA control group in the rate of severe adverse events (SAEs) involving the AV access circuit within 30 days. Through 12 months, the mortality rate was comparable between the IN.PACT AV DCB group and the PTA control group (9.4% vs. 9.6%, log-rank p=0.931).

“When treated with standard PTA, ESRD patients requiring AV fistula maintenance often have to undergo anywhere from 1-3 access procedures per year. This, in addition to their multiple weekly dialysis appointments, results in even more time spent in a healthcare setting,” said Terry Litchfield, M.P.H., president of Access Solutions, an organization focused on patient advocacy related to vascular access services. “These newly-published data on IN.PACT AV DCB not only show promise in keeping people living with ESRD out of the hospital for longer, they also demonstrate that using this DCB will reduce the number of interventions a patient will need each year, thus avoiding the time and expense of additional procedures to keep their dialysis access working well.”