Alert Indications, Safety, and Warnings

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter for femoropopliteal disease

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter is a clinically proven primary endovascular therapy that treats femoropopliteal disease. It is 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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Alert Indications, Safety, and Warnings

Overview

Tested. Trusted.

The IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter remains the market-leading DCB, backed by five years of efficacy data,1 even in complex lesions.2

See the data

Product details

Maintain long-term vessel patency with the IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter, which provides durable, consistent, and safe outcomes across multiple clinical trials, as well as across complex patient and lesion types. With more than 3,500 patients enrolled in 21 clinical studies and 500,000+ patients treated worldwide, the IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter is the best-selling DCB on the market for treatment of femoropopliteal disease.

Proven formulation of paclitaxel in tissue

Only the IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter releases the drug into the tissue through the restenotic window.

Duration of paclitaxel in tissue†

paclitaxel graph

Clinical evidence

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter, with drug in tissue up to 180 days,3 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

How it works

 IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter mechanism of action

See how the DCB works.

Ordering information 

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter

Feature

Specifications

Paclitaxel drug dose

3.5 µg/mm2

Excipient

Urea

Balloon diameters

4.0 to 7.0 mm

Balloon lengths

40, 60, 80, 120, 150, 200, and 250 mmll

Balloon fold configurations

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

Catheter design

Over-the-wire (OTW)

Catheter lengths

40, 80 and 130 cm

Guidewire compatibility

0.035 in

Ref. Number Usable Length 40cm

Ref. Number Usable Length 80cm

Ref. Number Usable Length 130cm

Balloon Diameter (mm)

Balloon length
(mm)

Recommended introducer
sheath (F)

RBP
(atm)
SBI 040 040 04P SBI 040 040 08P  SBI 040 040 13P 4.0 40 5 14
SBI 040 060 04P SBI 040 060 08P  SBI 040 060 13P 4.0 60 5 14
SBI 040 080 04P SBI 040 080 08P  SBI 040 080 13P 4.0 80 5 14
- SBI 040 120 08P  SBI 040 120 13P 4.0 120 5 14
- SBI 040 150 08P  SBI 040 150 13P 4.0 150 5 14
- SBI04020008P  SBI04020013P 4.0 200 5 11
- SBI04025008P  SBI04025013P 4.0 250 5 11
SBI 050 040 04P SBI 050 040 08P  SBI 050 040 13P 5.0 40 6 14
SBI 050 060 04P SBI 050 060 08P  SBI 050 060 04P 5.0 60 6 14
SBI 050 080 04P SBI 050 080 08P SBI 050 080 13P 5.0 80 6 14
- SBI 050 120 08P  SBI 050 120 13P 5.0 120 6 14
- SBI 050 150 08P  SBI 050 150 13P 5.0 150 6 14
- SBI05020008P  SBI05020013P 5.0 200 6 11
- SBI05025008P  SBI05025013P 5.0 250 6 11
SBI 060 040 04P  SBI 060 040 08P  SBI 060 040 13P 6.0 40 6 14
SBI 060 060 04P  SBI 060 060 08P  SBI 060 060 13P 6.0 60 6 14
SBI 060 080 04P  SBI 060 080 08P  SBI 060 080 13P 6.0 80 6 14
-  SBI 060 120 08P  SBI 060 120 13P 6.0 120 6 14
-  SBI 060 150 08P  SBI 060 150 13P 6.0 150 6 14
-  SBI06020008P  SBI06020013P 6.0 200 6 11
-  SBI06020008P  SBI06025013P 6.0 250 6 11
SBI 070 040 04P SBI 070 040 08P  SBI 070 040 13P 7.0 40 7 14
SBI 070 060 04P SBI 070 060 08P  SBI 070 060 13P 7.0 60 7 14
SBI 070 080 04P SBI 070 080 08P  SBI 070 080 13P 7.0 80 7 14
SBI 080 040 04P SBI 080 040 08P  SBI 080 040 13P 8.0 40 7 10
SBI 080 060 04P SBI 080 060 08P  SBI 080 060 13P 8.0 60 7 10
SBI 080 080 04P SBI 080 080 08P  SBI 080 080 13P 8.0 80 7 10
SBI 090 040 04P SBI 090 040 08P  SBI 090 040 13P 9.0 40 7 10
SBI 090 060 04P SBI 090 060 08P  SBI 090 060 13P 9.0 60 7 10
SBI 090 080 04P SBI 090 080 08P  SBI 090 080 13P 9.0 80 7 10
SBI 100 040 04P SBI 100 040 08P  SBI 100 040 13P 10.0 40 7 9
SBI 120 040 04P  SBI 120 040 08P  SBI 120 040 13P 12.0 40 9  9

IN.PACT™ Pacific™ Drug-Eluting Balloon+

Ref. Number Usable Length 90cm

Ref. Number Usable Length 130cm

Balloon Diameter (mm)

Balloon Length (mm)

Recommended Introducer Sheath (Fr)

RBP (atm)
PCF 040 040 09P PCF 040 040 13P 4 40 5 20
PCF 040 060 09P PCF 040 060 13P 4 60 5 14
PCF 040 080 09P PCF 040 080 13P 4 80 5 14
PCF 040 120 09P PCF 040 120 13P 4 120 5 14
PCF 050 040 09P PCF 050 040 13P 5 40 5 20
PCF 050 060 09P PCF 050 060 13P 5 60 5 14
PCF 050 080 09P PCF 050 080 13P 5 80 5 14
PCF 050 120 09P PCF 050 120 13P 5 120 5 14
PCF 060 040 09P PCF 060 040 13P 6 40 5 14
PCF 060 060 09P PCF 060 060 13P 6 60 5 16
PCF 060 080 09P PCF 060 080 13P 6 80 5 14
PCF 060 120 09P PCF 060 120 13P 6 120 5 14
PCF 070 040 09P PCF 070 040 13P 7 40 6 12
PCF 070 060 09P PCF 070 060 13P 7 60 6 12
PCF 070 080 09P PCF 070 080 13P 7 80 6 12
PCF 070 120 09P PCF 070 120 13P 7 120 6 12

Additional resources

Related pages

Technical manual

Instructions for manual use
Find this technical manual in the Medtronic Manual Library in the product labeling supplied with each device, or by calling Medtronic at 1-763-526-7890.

Connect with us

Reach a Medtronic sales rep
Contact us here

24-hour Technical Support
1-763-514-4000 (worldwide)
rs.cstechsupport@medtronic.com

*

™Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. The approved product name for the drug-coated balloon is IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter.

†

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.

§

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

FDA. PMA P140010: Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140010. Accessed May 23, 2022.

4

FDA. PMA P190019: Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190019. Accessed May 23, 2022.

5

Virmani R. 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):132-40.

6

FDA. PMA P160049: Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160049. Accessed May 23, 2022.

See product catalog for complete, detailed product information.