IN.PACT™ Admiral™ and IN.PACT™ 018 Paclitaxel-coated PTA Balloon Catheters 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†
- 80 cm and 130 cm catheter lengths
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‡
Clinical evidence
IN.PACT Admiral DCB has the:
- Highest patency benefit through three years compared to PTA§1
- 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 |
80 and 130 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 Paclitaxel-coated PTA Balloon Catheter
| Shaft 80cm | Shaft 130cm | Balloon diameter (mm) | Balloon length (mm) | Recommended Introducer Sheath (F) | Nominal pressure (atm) | RBP (atm) |
|---|---|---|---|---|---|---|
| IPB04004008P | IPB04004013P | 4 | 40 | 5 | 8 | 10 |
| IPB04006008P | IPB04006013P | 4 | 60 | 5 | 8 | 10 |
| IPB04008008P | IPB04008013P | 4 |
80 | 5 | 8 | 10 |
| IPB04010008P | IPB04010013P | 4 | 100 | 5 | 8 | 10 |
| IPB04012008P | IPB04012013P | 4 |
120 | 5 | 8 | 10 |
| IPB04015008P | IPB04015013P | 4 |
150 | 5 | 8 | 10 |
| IPB05004008P | IPB05004013P | 5 | 40 | 5 | 8 | 10 |
| IPB05006008P | IPB05006013P | 5 |
60 | 5 | 8 | 10 |
| IPB05008008P | IPB05008013P | 5 |
80 | 5 | 8 | 10 |
| IPB05010008P | IPB05010013P | 5 | 100 | 5 | 8 | 10 |
| IPB05012008P | IPB05012013P | 5 |
120 | 5 | 8 | 10 |
| IPB05015008P | IPB05015013P | 5 | 150 | 5 | 8 | 10 |
| IPB06004008P | IPB06004013P | 6 |
40 | 5 | 8 | 10 |
| IPB06006008P | IPB06006013P | 6 |
60 | 5 | 8 | 10 |
| IPB06008008P | IPB06008013P | 6 | 80 | 5 | 8 | 10 |
| IPB06010008P | IPB06010013P | 6 |
100 | 5 | 8 | 10 |
| IPB06012008P | IPB06012013P | 6 |
120 | 5 | 8 | 10 |
| IPB06015008P | IPB06015013P | 6 | 150 | 5 | 8 | 10 |
| IPB07004008P | IPB07004013P | 7 | 40 | 6 | 8 | 10 |
| IPB07006008P | IPB07006013P | 7 |
60 | 6 | 8 | 10 |
| IPB07008008P | IPB07008013P | 7 |
80 | 6 | 8 | 10+ |
IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter
| Ref. Number Usable Length 40cm |
Ref. Number Usable Length 80cm |
Ref. Number Usable Length 130cm |
Balloon Diameter (mm) |
Balloon length |
Recommended introducer |
RBP |
|---|---|---|---|---|---|---|
| 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 |
| - | SBI06025008P | 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 |
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.
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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.
See product catalog for complete, detailed product information.