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Get ahead of AV fistula restenosis1

IN.PACT™ AV Drug-Coated Balloon (DCB)
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Alert Indications, Safety, and Warnings

36-month data unveiled

IN.PACT AV DCB is the first and only DCB to show superior and sustained results at three years in treating AVF lesions, compared to PTA.2,3

See the Data

New England Journal of Medicine publishes largest AV DCB  pivotal trial*

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56% fewer reinterventions1 more of what matters

Patients treated with IN.PACT AV DCB show reduced need for reinterventions compared to PTA. This can help enable longer periods of uninterrupted dialysis, which could positively impact patients’ lives.1

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IN.PACT AV DCB Highest reported primary patency†1

78% Highest reported access circuit primary patency†1

86% Highest Reported Target Lesion Primary Patency†1

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Proactive approach

IN.PACT AV DCB can slow the progression of fistula stenosis. A functioning fistula can eliminate the need for catheter-based dialysis, decreasing risk of infection and all-cause mortality.1

Fewer is better

The IN.PACT AV DCB may enable dramatically fewer AV fistula reinterventions, which could keep patients out of the hospital longer.1 It can make a real impact — clinically, financially,4 and emotionally.

Hear from Dominick ― a patient story.

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*

The largest global, randomized, AV fistula drug-coated balloon study conducted, with subjects from Japan, New Zealand, and the United States.

†

In an AV DCB study at 6 months.

References

1

Lookstein RA, Haruguchi H, Ouriel K, et al. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. 2020;383(8):733-742.

2

Holden A. The IN.PACT AV Access Study: Results through 36 Months. Presented at Charing Cross 2022.

3

Trerotola SO, Saad TF, Roy-Chaudhury P; Lutonix AV Clinical Trial Investigators. The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis. J Vasc Interv Radiol. 2020;31(1):1-14.e5.

4

Thamer M, Lee TC, Wasse H, et al. Medicare Costs Associated With Arteriovenous Fistulas Among US Hemodialysis Patients. Am J Kidney Dis. 2018;72(1):10-18.

Target Lesion Primary Patency Rate based on KM estimates: Defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis calculated at 180 days.

Access Circuit Primary Patency based on KM estimates: Defined as freedom from reintervention in the access circuit or access circuit thrombosis calculated at 180 days.

Reduction in reinterventions: Defined as the number of interventions required to maintain target lesion primary patency calculated at 210 days.