IN.PACT™ AV drug-coated balloon
Clinical evidence
A clinical review of IN.PACT™ AV drug-coated balloon (DCB) and other therapies for arteriovenous (AV) fistula maintenance
IN.PACT™ AV DCB:
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.
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.
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.
The Use of DCB for AV Fistulas — CME (FPO)
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.