IN.PACT™ AV drug-coated balloon is the proactive AV maintenance treatment option that offers superior performance compared to PTA,1 fewer reinterventions,2 and a clear path for the dialysis lifeline.
Extend time between interventions.
AV access maintenance trials — target lesion primary patency†
IN.PACT™ AV DCB can extend the time between interventions by ~14.7 months1 — more than 5× longer than Lutonix™* DCB.3
† Primary patency endpoints are defined differently; results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only.
Risks may include: pain; hemorrhage; arterial or venous aneurysm/thrombosis, dissection, infection, perforation, or rupture; loss of permanent access; allergic/immunologic reaction; and death.
First and only DCB with superior, sustained results at 36 months1,3
Results from separate trials comparing drug-coated balloons to standard PTA for AV fistula maintenance
Target lesion primary patency at 36 months† IN.PACT™ AV DCB‡,1
Access circuit primary patency at 36 months† IN.PACT™ AV DCB§,1
No statistical difference in all-cause mortality between PTA and IN.PACT™ AV DCB at 36 months1
Target lesion primary patency at 24 months† Lutonix™* DCB◊,3
Access circuit primary patency at 24 months† Lutonix™* DCB¶,3,8
† Primary patency endpoints are defined differently; results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only.
Significantly reduces access circuit thrombosis1
56% fewer reinterventions.2 More of what matters.
Patients treated with IN.PACT™ AV DCB demonstrate a reduced need for reinterventions compared to PTA. This can help enable longer periods of uninterrupted dialysis and could keep patients out of the hospital longer, which may positively impact patients’ lives.2
Watch Dianne’s story to see how this proactive maintenance treatment helped decrease the number of maintenance procedures she needed, allowing her to focus on the things she loves most.
Proactive approach
The 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.2
IN.PACT™ AV DCB minimizes the potential post-treatment limitations of stents, leaving a clear path for the dialysis lifeline.
TM* Third-party brands are trademarks of their respective owners.
† Primary patency endpoints are defined differently; results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only.
‡ IN.PACT™ AV Access Trial: target lesion primary patency rate was defined as freedom from clinically driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 36 months (1,080 days) post-procedure.
§ IN.PACT™ AV Access Trial: access circuit primary patency was defined as freedom from reintervention in the access circuit or access circuit thrombosis measured through 36 months (1,080 days) post-procedure.
◊ Lutonix™* AV Clinical Trial: target lesion primary patency was defined as freedom from clinically driven reintervention of the target lesion or access thrombosis measured through 24 months.
¶ Lutonix™* AV Clinical Trial: access circuit primary patency was defined as freedom from access circuit revascularization or access circuit thrombosis measured through 24 months.
Lookstein RA, Haruguchi H, Suemitsu K, et al. IN.PACT AV access randomized trial of drug-coated balloons for dysfunctional arteriovenous fistulae: clinical outcomes through 36 months. J Vasc Interv Radiol. 2023;34(12):2093–2102.e7. doi:10.1016/j.jvir.2023.07.007.
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. doi:10.1056/NEJMoa1914617. Highlighted results reported at both 180 and 210 days.
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. doi:10.1016/j.jvir.2019.08.035.
Flair™* Endovascular Stent Graft instructions for use.
Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg. 2016;64(5):1400–1410.e1. doi:10.1016/j.jvs.2016.04.035.
Falk A, Maya ID, Yevzlin AS, RESCUE Investigators. A prospective, randomized study of an expanded polytetrafluoroethylene stent graft versus balloon angioplasty for in-stent restenosis in arteriovenous grafts and fistulae: Two-year results of the RESCUE Study. J Vasc Interv Radiol. 2016;27(10):1465–1476. doi:10.1016/j.jvir.2016.06.014.
Dolmatch B, Cabrera T, Pergola P, et al. Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis. Kidney Int. 2023;104(1):189–200. doi:10.1016/j.kint.2023.03.015.
Lutonix™* 035 Drug Coated Balloon PTA CatheterModel 9010 instructions for use.
