IN.PACT AV

Drug-Coated Balloon (DCB)
for Arteriovenous Access Maintenance

The IN.PACT™ AV DCB has been demonstrated superior to PTA in increasing patency and prolonging time between AV fistula interventions.1

In separate IN.PACT AV* and Lutonix AV clinical trials, only IN.PACT AV DCB met its effectiveness endpoint.1,2

VIEW BROCHURE

Overview

GET AHEAD
OF AV Fistula
RESTENOSIS1

In the largest randomized AV DCB study conducted,‡  IN.PACT AV DCB reduced interventions by more than 56% over PTA,1 slowing the progression of stenosis and helping preserve the fistula for dialysis. 

INDICATIONS

The IN.PACT AV paclitaxel-coated PTA balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.

PRODUCT DETAILS

The IN.PACT AV DCB is a clinically demonstrated endovascular therapy for End Stage Renal Disease (ESRD) patients with a narrowed AV fistula. It delivers an antiproliferative drug (paclitaxel) to the vessel to inhibit neointimal hyperplasia (NIH), the primary cause of AV fistula stenosis. The proprietary design enables the IN.PACT AV DCB to deliver sustained drug levels and unparalleled clinical results.1

EFFICIENT DELIVERY

A proprietary combination of paclitaxel drug and urea exipient allows rapid transfer of the antiproliferative drug to the vessel wall.4

SUSTAINED DURATION

Reservoirs of the drug stay in the vessel wall, capable of delivering effective paclitaxel levels by residing in the vessel for up to 180 days.4

EXTENDED EFFECT

Uniquely combining an appropriate dosage for an appropriate amount of time,4 the IN.PACT AV DCB can dramatically reduce the need for repair procedures.1

HOW IT WORKS

Mechanism of action

The IN.PACT AV DCB is coated with a unique combination of paclitaxel, an anti-proliferative drug, and an excipient, urea. This unique formulation allows the drug to be rapidly transferred to the vessel wall and then remain in the vessel for up to 180 days.4

SPECIFICATIONS

IN.PACT AV DCB PRODUCT CHARACTERISTICS 

Product Characteristic Description

Balloon Coating

Paclitaxel and urea

Paclitaxel Drug Dose

3.5 μg/mm2

Balloon Diameters

4.0 to 12.0 mm

Balloon Fold Configuration

4.0 mm 3 folds; 5 -  12 mm 6 folds

Balloon Lengths

40 to 120 mm

Catheter Effective Length

40, 80 and 130 cm

Guidewire Compatibility

0.035"

Catheter Shaft Design

Over-the-Wire (OTW)

Shaft Diameter

5 Fr

Introducer Sheath Compatibility

4.0 mm - 5 Fr; 5.0 - 6.0 mm - 6 Fr; 7.0 - 10 mm - 7 Fr; 12.0 mm - 9 Fr.

Nominal Balloon Pressure

4.0 - 9.0 mm - 8 atm; 10.0 - 12.0 mm - 6 atm

Rated Burst Pressure

4.0 - 7.0 mm - 14 atm; 8.0 - 9.0 mm - 10 atm; 10.0 mm - 9 atm; 12.0 mm - 9 atm

Sterilization Method

Ethylene Oxide (ETO)

Ordering Information

PRODUCT MANUALS

Access product manuals from the Medtronic Manual Library by searching for the product name or product number.

VISIT LIBRARY

CONNECT WITH US

Connect with a representative or receive more information about IN.PACT AV or any other product in our Peripheral portfolio.

SUBMIT YOUR REQUEST

Contact Information

CardioVascular Lifeline Customer Support

+1-763-526-7890
rs.cstechsupport@medtronic.com

Orders

+1-763-514-8510
rs.cuvasorders@medtronic.com

24-hour Technical Support

+1-763-514-4000 (Worldwide)
*

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 210 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 at 180 days.

The largest global, randomized, AV fistula drug-coated balloon study conducted, with subjects from Japan, New Zealand, and the United States.

1

Results from the IN.PACT™ AV Access Clinical Trial found in the IN.PACT™ AV drug-coated balloon (DCB) Instructions For Use (IFU).

2

Lutonix IFU LUTONIX® 035 Drug Coated Balloon PTA Catheter Model 9010

3

Medicare Costs Associated with Arteriovenous Fistulas Among US Hemodialysis Patients, Thamer et al., AJKD, March 2018 ; Patients who initiated HD with a catheter.

4

Data on file at Medtronic.

Reduction in reinterventions: Defined as the number of interventions required to maintain target lesion primary patency calculated at 210 days.