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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>

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Product details

This is an image of the IN.PACT™ Admiral™ or IN.PACT™ 018 drug-coated balloon.

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
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†
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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◊

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 cm and 130 cm
Balloon diameters 4.0 to 7.0 mm 4.0 to 7.0 mm
Balloon lengths 40, 60, 80, 120, 150 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 Balloon
diameter (mm)		 Balloon
length (mm)		 Recommended
introducer
sheath (Fr)		 Nominal
Pressure (atm)		 RBP (atm)
IPU04004013P 4.0 40 5 8 10
IPU04006013P 4.0 60 5 8 10
IPU04008013P 4.0 80 5 8 10
IPU04010013P 4.0 100 5 8 10
IPU04012013P 4.0 120 5 8 10
IPU04015013P 4.0 150 5 8 10
IPU05004013P 5.0 40 5 8 10
IPU05006013P 5.0 60 5 8 10
IPU05008013P 5.0 80 5 8 10
IPU05010013P 5.0 100 5 8 10
IPU05012013P 5.0 120 5 8 10
IPU05015013P 5.0 150 5 8 10
IPU06004013P 6.0 40 5 8 10
IPU06006013P 6.0 60 5 8 10
IPU06008013P 6.0 80 5 8 10
IPU06010013P 6.0 100 5 8 10
IPU06012013P 6.0 120 5 8 10
IPU06015013P 6.0 150 5 8 10
IPU07004013P 7.0 40 6 8 10
IPU07006013P 7.0 60 6 8 10
IPU07008013P 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 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 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 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 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. Some products may not be  licensed in Canada.

This product is licenced with Health Canada as IN.PACT ADMIRAL PACLITAXEL-COATED PTA BALLOON CATHETER on Health Canada licence number MDL 98019, and IN.PACT 018 PACLITAXEL-COATED PTA BALLOON CATHETER on Health Canada licence number MDL 111392.