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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Overview
Product details
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
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
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‡
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||
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 |
4.0 mm: 3 folds |
| Paclitaxel drug dose |
3.5 µg/mm2 |
3.5 µg/mm2 |
| Excipient |
Urea |
Urea |
IN.PACT 018 DCB ordering information
| Model number |
Model number |
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 |
Model number |
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.