Clinical review
of IN.PACT AV drug-coated balloon
A clinical review of IN.PACT™ AV drug-coated balloon (DCB) and other therapies for 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
- Offers superior performance compared to PTA through 36 months2
AV maintenance trial review
Only device to achieve > 80% primary patency† through six months in an AVF trial
IN.PACT AV DCB treats the cause of restenosis — not just the symptoms — helping to move your patients in the right direction.
AV access maintenance trials — target lesion primary patency‡
See six-month outcomes from separate AV access maintenance trials evaluating PTA balloons, stents, and DCBs.†
† Target lesion primary patency in an AV fistula IDE randomized controlled trial.
‡ 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.
36-month data
First and only DCB with superior, sustained results at 36 months2,10
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
Target lesion primary patency at 24 months‡
Lutonix DCB||10
Access circuit primary patency at 36 months‡
IN.PACT AV DCB¶2
Access circuit primary patency at 24 months‡
Lutonix DCB#10,11
‡ 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.
|| 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.
¶ 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: Access circuit primary patency was defined as freedom from access circuit revascularization or access circuit thrombosis measured through 24 months.
IN.PACT AV trial six-month results published
in The New England Journal of Medicine.
IN.PACT AV DCB product details
*
Third-party brands are trademarks of their respective owners.
†
Target lesion primary patency in an AV fistula IDE randomized controlled trial.
‡
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.
||
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.
¶
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: Access circuit primary patency was defined as freedom from access circuit revascularization or access circuit thrombosis measured through 24 months.
References
1
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.
2
Holden A. The IN.PACT AV Access Study: Results through 36 Months. Presented at Charing Cross 2022.
3
Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF; Lutonix AV Clinical Trial Investigators. Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial. Clin J Am Soc Nephrol. August 7, 2018;13(8):1215-1224.
4
Dolmatch B. Presented at LINC 2020; Leipzig, Germany.
5
Dolmatch B. Presented at CIRSE 2020; Virtual.
6
Covera covered stent Instructions for Use.
7
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. October 2016;27(10):1465-1476.
8
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. November 2016;64(5):1400-1410.
9
Flair Endovascular Stent Graft Instructions for Use.
10
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. January 2020;31(1):1-14.e5.
11
LUTONIX 035 drug coated balloon PTA Catheter Instructions for Use.