Alert Indications, Safety, and Warnings

IN.PACT Admiral and IN.PACT 018
drug-coated balloons for femoropopliteal disease

The IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons (DCB) are primary endovascular therapies that treat femoropopliteal disease. They are indicated for de novo, restenotic, or in-stent restenotic lesions up to 360 mm, with reference vessel diameters of 4 to 7 mm.

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IN.PACT Admiral or IN.PACT 018 drug-coated balloon on white background
Alert Indications, Safety, and Warnings

Overview

Product details

IN.PACT Admiral drug-coated balloon on white background

IN.PACT Admiral DCB

  • Compatible with 0.035" guidewires
  • Tested and trusted, with more than 500,000 patients treated worldwide
  • Five years of efficacy and safety data,1 even in complex lesions2
  • Available in 200 mm and 250 mm balloon lengths
     
See brochure
IN.PACT 018 drug-coated balloon on white background

IN.PACT 018 DCB

  • Compatible with 0.018" guidewires
  • Uses the same proven drug formulation as IN.PACT Admiral DCB
  • Low-profile design provides better deliverability†
  • 130 cm and 200 cm catheter lengths allow the option to treat via femoral or radial access
View brochure
pdf Outcomes Protection Program (.pdf)

Both IN.PACT DCBs are backed by our Outcomes Protection Program. We're so confident in our clinical outcomes that we will share in the cost of care if your patients require reintervention within one year of treatment.

3.3MB

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Proven formulation of paclitaxel in tissue

Only IN.PACT Admiral and IN.PACT 018 DCBs release the drug into tissue through the restenotic window.

Duration of paclitaxel in tissue‡

Bar chart of the number of days paclitaxel is measured in tissue for IN.PACT Admiral and 018, Lutonix, Ranger, and Stellarex

Days after index procedure

Clinical evidence

IN.PACT Admiral DCB has the:

  • Highest patency benefit through three years compared to PTA§1
  • Lowest CD-TLR rate through five years1
  • Most publications for a DCB||

View clinical data

The safety and effectiveness of the IN.PACT Admiral DCB (0.035 in guidewire compatible), as established in the clinical studies that were performed primarily via femoral access, can be considered supportive for the IN.PACT 018 DCB. The IN.PACT 018 DCB has not been evaluated in a clinical study.

How it works

Uniquely made to deliver unmatched results compared to PTA

IN.PACT DCBs are coated with a combination of paclitaxel and an excipient, urea. The unique formulation allows rapid and efficient delivery of drug to the vessel wall.

Watch a video to see how our DCBs work.

Ordering information 

Features

Specifications

IN.PACT Admiral DCB

IN.PACT 018 DCB

Guidewire compatibility

0.035 in

0.018 in

Catheter design

Over-the-wire (OTW)

Over-the-wire (OTW)

Catheter lengths

80 and 130 cm

130 and 200 cm

Balloon diameters

4.0 to 7.0 mm

4.0 to 7.0 mm

Balloon lengths

40, 60, 80, 120, 150, 200, 250 mm

40, 60, 80, 100, 120, 150 mm

Balloon fold configurations

4.0 mm: 3 folds
5.0, 6.0, and 7.0 mm: 6 folds

4.0 mm: 3 folds
5.0, 6.0, and 7.0 mm: 6 folds

Paclitaxel drug dose

3.5 µg/mm2

3.5 µg/mm2

Excipient

Urea

Urea

IN.PACT 018 DCB ordering information

Model number
(130 cm catheter)

Model number
(200 cm catheter)

Balloon diameter (mm)

Balloon length (mm)

Recommended introducer sheath (F)

Nominal pressure (atm)

RBP (atm)

IPU04004013P

IPU04004020P

4.0

40

5

8

10

IPU04006013P

IPU04006020P

4.0

60

5

8

10

IPU04008013P

IPU04008020P

4.0

80

5

8

10

IPU04010013P

IPU04010020P

4.0

100

5

8

10

IPU04012013P

IPU04012020P

4.0

120

5

8

10

IPU04015013P

IPU04015020P

4.0

150

5

8

10

IPU05004013P

IPU05004020P

5.0

40

5

8

10

IPU05006013P

IPU05006020P

5.0

60

5

8

10

IPU05008013P

IPU05008020P

5.0

80

5

8

10

IPU05010013P

IPU05010020P

5.0

100

5

8

10

IPU05012013P

IPU05012020P

5.0

120

5

8

10

IPU05015013P

IPU05015020P

5.0

150

5

8

10

IPU06004013P

IPU06004020P

6.0

40

5

8

10

IPU06006013P

IPU06006020P

6.0

60

5

8

10

IPU06008013P

IPU06008020P

6.0

80

5

8

10

IPU06010013P

IPU06010020P

6.0

100

5

8

10

IPU06012013P

IPU06012020P

6.0

120

5

8

10

IPU06015013P

IPU06015020P

6.0

150

5

8

10

IPU07004013P

IPU07004020P

7.0

40

6

8

10

IPU07006013P

IPU07006020P

7.0

60

6

8

10

IPU07008013P

IPU07008020P

7.0

80

6

8

10

IN.PACT Admiral DCB ordering information

Model number
(80 cm catheter)

Model number
(130 cm catheter)

Balloon diameter (mm)

Balloon length (mm)

Recommended introducer sheath (F)

Nominal pressure (atm)

RBP (atm)

ADM 040 040 08P

ADM 040 040 13P

4.0

40

5

8

14

ADM 040 060 08P

ADM 040 060 13P

4.0

60

5

8

14

ADM 040 080 08P

ADM 040 080 13P

4.0

80

5

8

14

ADM 040 120 08P

ADM 040 120 13P

4.0

120

5

8

14

ADM 040 150 08P

ADM 040 150 13P

4.0

150

5

8

14

 

ADM 040 200 13P

4.0

200

5

5

11

 

ADM 040 250 13P

4.0

250

5

5

11

ADM 050 040 08P

ADM 050 040 13P

5.0

40

6

8

14

ADM 050 060 08P

ADM 050 060 13P

5.0

60

6

8

14

ADM 050 080 08P

ADM 050 080 13P

5.0

80

6

8

14

ADM 050 120 08P

ADM 050 120 13P

5.0

120

6

8

14

ADM 050 150 08P

ADM 050 150 13P

5.0

150

6

8

14

 

ADM 050 200 13P

5.0

200

6

5

11

 

ADM 050 250 13P

5.0

250

6

5

11

ADM 060 040 08P

ADM 060 040 13P

6.0

40

6

8

14

ADM 060 060 08P

ADM 060 060 13P

6.0

60

6

8

14

ADM 060 080 08P

ADM 060 080 13P

6.0

80

6

8

14

ADM 060 120 08P

ADM 060 120 13P

6.0

120

6

8

14

ADM 060 150 08P

ADM 060 150 13P

6.0

150

6

8

14

 

ADM 060 200 13P

6.0

200

6

5

11

 

ADM 060 250 13P

6.0

250

6

5

11

ADM 070 040 08P

ADM 070 040 13P

7.0

40

7

8

14

ADM 070 060 08P

ADM 070 060 13P

7.0

60

7

8

14

ADM 070 080 08P

ADM 070 080 13P

7.0

80

7

8

14

See the product catalog for complete, detailed product information.

Additional resources

Related pages

Instructions for manual use

Find the technical manuals in the Medtronic Manual Library, in the product labeling supplied with each device, or by calling Medtronic at 763-526-7890.

Connect with us

Reach a Medtronic sales rep
Contact us here

CardioVascular Lifeline Customer Support
763-526-7890
rs.cstechsupport@medtronic.com

Orders
763-514-8510
rs.cuvasorders@medtronic.com

24-hour technical support
763-514-4000 (worldwide)

The safety and effectiveness of the IN.PACT Admiral DCB (0.035 in guidewire compatible), as established in the clinical studies that were performed primarily via femoral access, can be considered supportive for the IN.PACT 018 DCB. The IN.PACT 018 DCB has not been evaluated in a clinical study.

*

™Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

†

Data on file with Medtronic.

‡

Data comes from different individual studies and may differ in a head-to-head comparison, and therefore may not be predictive of clinical results.

§

Primary patency not assessed after three years.

||

List of publications on file with Medtronic.

120, 150, 200, and 250 mm lengths are not offered on the 7.0 mm diameter balloon.

References

1

Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. 5-year results from the IN.PACT SFA Trial. Circ Cardiovasc Interv. June 2019;12(6):e007702.

2

Tepe G. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA, 2021.

3

PMA P140010: Summary of safety and effectiveness data. FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140010. Accessed September 26, 2022.

4

PMA P190019: Summary of safety and effectiveness data. FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190019. Accessed September 26, 2022.

5

Yazdani SK, Pacheco E, Nakano M, et al. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. January 1, 2014;83(1):132-140.

6

PMA P160049: Summary of safety and effectiveness data. FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160049. Accessed September 26, 2022.