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.&nbsp;</p>

Ordering information
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Product details

The IN.PACT Admiral and IN.PACT 018 drug-coated balloons are clinically proven, primary endovascular therapies that treats femoropopliteal disease, reduce interventions, and preserve future treatment options.

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
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The IN.PACT 018 drug-coated balloon (DCB) is a low-profile DCB designed to treat femoropopliteal disease.

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
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Outcomes protection program

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.

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‡

See a comparison of drug-coated balloon duration in tissue results, up to 180 days.

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 evidence

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 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

Ordering information

IN.PACT™ 018 DCB

130 cm catheter 200 cm catheter Balloon
diameter (mm)		 Balloon
length (mm)		 Recommended
introducer
sheath (Fr)		 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

80 cm catheter 130 cm catheter Balloon
diameter (mm)		 Balloon
length (mm)		 Recommended
introducer
sheath (Fr)		 Nominal
Pressure (atm)		 RBP (atm)
ADM040 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

Related links

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.

  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. 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. 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.