Peripheral drug-coated balloons
IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons
<p>The IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons (DCB) are proven treatments for femoropopliteal disease. </p>
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 the IN.PACT™ Admiral™ and IN.PACT™ 018 DCBs release the drug into the 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.
Specifications
| Features | 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 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 |
Manuals and Technical Guides
Instructions for Use
Find this technical manual in the product labeling supplied with each device.
Ordering information
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(mm) |
Balloon Recommended 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 |
| - | 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 |
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.
* Complications associated with radial access may include but are not limited to: abrupt vessel closure, vessel spasm, perforation or rupture of the artery, dissection, pseudoaneurysm, hematoma, thrombosis, and stroke.
TM* 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.
- 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. 2019;12(6):e007702.
- Tepe G. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA, 2021.
- 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.
- 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.
- 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. 2014;83(1):132-140.
- 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.