Clinical Review 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

The proactive approach for AV fistula maintenance in end-stage renal disease (ESRD) patients

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 to PTA through 24 months2

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.

First and Only DCB with Superior, Sustained Results Through 24 Months2,11

The highest reported primary patency of any DCB at 24 months.

24-month results from separate trials comparing drug-coated balloons to standard PTA for AV fistula maintenance.

Target Lesion Primary Patency Through 24 Months

IN.PACT AV DCB§2

Blue and green Kaplan-Meier chart showing IN.PACT AV DCB target lesion primary patency at 24 months versus PTA

Lutonix®* DCBll11

Blue and green Kaplan-Meier chart showing Lutonix DCB target lesion primary patency at 24 months versus PTA

Access Circuit Primary Patency at 24 Months

IN.PACT AV DCB¶2

Blue and green Kaplan-Meier chart showing IN.PACT AV DCB access circuit primary patency at 24 months versus PTA

Lutonix DCB#11,12

Blue and green Kaplan-Meier chart showing Lutonix DCB access circuit primary patency at 24 months versus PTA

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 Trial 6-month Results Published

in The New England Journal of Medicine.

Review Manuscript

IN.PACT AV DCB Product  Details

Learn More
*

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 720 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 720 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. IN.PACT AV Access Investigators. 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. Presented at Charing Cross 2021.

3

Lookstein RA, Haruguchi H, Ouriel K, et al. IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. August 20, 2020;383(8):733-742.

4

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.

5

Dolmatch B. LINC 2020; Leipzig, Germany.

6

Dolmatch B. CIRSE 2020; Virtual.

7

Covera™* Covered Stent Instructions for Use.

8

Falk A, Maya ID, Yevzlin AS; RESCUE Investigators. J Vasc Interv Radiol. October 2016;27(10):1465-1476.

9

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.

10

Flair™* Endovascular Stent Graft Instructions for Use.

11

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.

12

LUTONIX®* 035 Drug Coated Balloon PTA Catheter Instructions for Use.