A clinical review of IN.PACT™ AV drug-coated balloon (DCB) and other therapies for arteriovenous (AV) fistula maintenance
Leave a clear path for the dialysis lifeline.
IN.PACT™ AV DCB:
Demonstrates 56% fewer reinterventions than PTA1
Slows the progression of restenosis
Minimizes the potential post-treatment limitations of stents
Extends the time between interventions by ~14.7 months2
Offers superior performance compared to PTA through 36 months2
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 months2 – 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.
36-month data
First and only DCB with superior, sustained results at 36 months2,3
Compared to PTA, the IN.PACT™ AV drug-coated balloon is the first and only DCB to show both superior and sustained results at 36 months in treating AV fistula lesions.
The highest reported primary patency of any DCB at 36 months
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‡,2
Access circuit primary patency at 36 months†
IN.PACT™ AV DCB§,2
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 rates are defined differently; results are from different studies and may vary in a head-to-head comparison; charts are for illustration purposes only.
TM*Third-party brands are trademarks of their respective owners.
† Primary patency rates 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, Ouriel K, et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med. August 20, 2020;383(8):733–742. Highlighted results reported at both 180 and 210 days.
Lookstein RA, Haruguchi H, Suemitsu K, et al. IN.PACT AV access randomized trial of drug-coated balloons for dysfuntional 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.
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.
