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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>


Drug-coated balloons


View the IN.PACT™ Admiral™ drug-coated balloon (DCB).

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
View the IN.PACT™ 018 drug-coated balloon (DCB).

IN.PACT™ 018 DCB

  • Compatible with 0.014" and 0.018" guidewires
  • Uses the same proven drug formulation as IN.PACT™ Admiral™ DCB
  • Available in 200 mm and 250 mm balloon lengths
  • 130 cm and 200 cm catheter lengths allow the option to treat via femoral or radial access

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

View this chart comparing the duration of paclitaxel in tissue after a drug-coated balloon procedure.

Competitive DCB indications

Product SFA/Popliteal SFA/Popliteal lesions over 180 mm ISR
IN.PACT™ Admiral™ DCB
IN.PACT™ 018 DCB
Ranger™* DCB X X
Lutonix™* DCB
Stellarex™* DCB X
Surveil™* DCB X X

 



Backed by unmatched clinical evidence

IN.PACT™ Admiral™ DCB is the only DCB that has:

  • Demonstrated a statistically significant delta versus PTA for primary patency at three years§,1
  • Demonstrated a statistically significant delta versus PTA for freedom from CD-TLR at five years1
  • Five-year data on ISR, CTO, and long lesions1
  • More than 30 sponsored publications

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 has not been evaluated in a clinical study. 

Risks may include: access site pain or infection, hemorrhage, local or distal embolic events, perforation or rupture of the artery, amputation and death.



Mechanism of action: Efficient drug delivery

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.



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.



Frequently asked questions

Risks may include: access site pain or infection, hemorrhage, local or distal embolic events, perforation or rupture of the artery, amputation and death.

IN.PACT™ Admiral™ and IN.PACT™ 018 DCBs are the only DCBs to treat lesions in the SFA with drug-in tissue through the restenotic window.3-6 IN.PACT™ Admiral™ DCB is the only DCB backed by more than 30 publications and IN.PACT™ 018 DCB is the only 0.018" DCB platform with a 250 mm length balloon.


IN.PACT™ Admiral™ DCB is supported by extensive multiyear data across randomized trials and global registries, including complex lesion subsets such as in-stent restenosis (ISR), long lesions, and chronic total occlusions (CTOs). With more than 30 peer-reviewed publications, IN.PACT™ Admiral™ has the largest clinical evidence base of any DCB, including follow-up out to 5 years.


Yes. Real‑world quality‑of‑life outcomes were reported in the French Post‑Reimbursement Registry, presented by Professor Yann Gouëffic at the 2025 Paris Vascular Insights Course:

  •  In the real-world study of 80 patients — 36% with diabetes, 33% with critical limb ischemia, and 35% with total occlusions — treatment with IN.PACT™ Admiral™ DCB led to significant improvements in quality of life (EQ‑5D‑5L) and walking ability by 12 months.7
  • Clinical outcomes found 98.8% freedom from major amputation, 84.4% freedom from target vessel revascularization through 24 months and a drop in critical limb ischemia rates from 32.5% to 3% at one year.7

This analysis is part of the Medtronic Product Surveillance Registry.


Randomized evidence from the IN.PACT™ SFA trial shows that IN.PACT™ Admiral™ DCB provides significantly better long-term patency than PTA.1 Through three years, IN.PACT™ Admiral™ DCB demonstrated a +24.4% higher primary patency compared to PTA , with primary patency rates of 62.0% for IN.PACT™ Admiral™ DCB versus 45.1% for PTA at 37 months (p < 0.001).

Long-term durability is further supported by the finding that 75% of patients treated with IN.PACT™ Admiral™ DCB remained reintervention-free at five years.1


Drug: Paclitaxel
Dose: 3.5 µg/mm2
Excipient: Urea

The unique formulation used in IN.PACT™ drug-coated balloons allows rapid and efficient delivery of drug to the vessel wall. Paclitaxel is an anti‑proliferative agent that inhibits the cell types involved in the restenotic cascade. Embedded paclitaxel crystals dissolve slowly into tissue, providing controlled, extended drug release for up to 180 days.3


IN.PACT™ Admiral™ and IN.PACT™ 018 DCBs are indicated for treatment of de novo, restenotic, or in‑stent restenotic lesions up to 360 mm in the superficial femoral and popliteal arteries with reference vessel diameters of 4 mm to 7 mm.



Specifications

 

Features

IN.PACT™ Admiral™ DCB

IN.PACT™ 018 DCB

Guidewire compatibility

0.035 in

0.014 and 0.018 in

Catheter design

Over-the-wire (OTW)

Over-the-wire (OTW)

Catheter lengths

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, 200, 250 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™ Admiral™ DCB

130 cm catheter Balloon
diameter (mm)
Balloon
length (mm)
Recommended
introducer
sheath (Fr)
Nominal
pressure (atm)
RBP (atm)
ADM04004013P 4.0 40 5 8 14
ADM04006013P 4.0 60 5 8 14
ADM04008013P 4.0 80 5 8 14
ADM04012013P 4.0 120 5 8 14
ADM04015013P 4.0 150 5 8 14
ADM04020013P 4.0 200 5 5 11
ADM04025013P 4.0 250 5 5 11
ADM05004013P 5.0 40 6 8 14
ADM05006013P 5.0 60 6 8 14
ADM05008013P 5.0 80 6 8 14
ADM05012013P 5.0 120 6 8 14
ADM05015013P 5.0 150 6 8 14
ADM05020013P 5.0 200 6 5 11
ADM05025013P 5.0 250 6 5 11
ADM06004013P 6.0 40 6 8 14
ADM06006013P 6.0 60 6 8 14
ADM06008013P 6.0 80 6 8 14
ADM06012013P 6.0 120 6 8 14
ADM06015013P 6.0 150 6 8 14
ADM06020013P 6.0 200 6 5 11
ADM06025013P 6.0 250 6 5 11
ADM07004013P 7.0 40 7 8 14
ADM07006013P 7.0 60 7 8 14
ADM07008013P 7.0 80 7 8 14

 

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
IPU04020013P IPU04020020P 4.0 200 5 8 10
IPU04025013P IPU04025020P 4.0 250 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
IPU05020013P IPU05020020P 5.0 200 5 8 10
IPU05025013P IPU05025020P 5.0 250 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
IPU06020013P IPU06020020P 6.0 200 5 8 10
IPU06025013P IPU06025020P 6.0 250 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

 

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.

TM* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

† 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.

‡ 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: Five-year outcomes from the IN.PACT SFA randomized trial. Circ Cardiovasc Interv. 2019;12(6):e007702. doi:10.1161/CIRCINTERVENTIONS.118.007702.
  2. Tepe G. 5-year results from the IN.PACT Global Study prespecified cohorts: ISR, CTO and long lesions. Presented at: VIVA 2021; October 3–7, 2021; Las Vegas, NV.
  3. FDA. PMA P140010: Summary of safety and effectiveness data. Accessed January 2, 2026.
  4. FDA. PMA P190019: Summary of safety and effectiveness data. Accessed January 2, 2026.
  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. doi:10.1002/ccd.24995.
  6. FDA. PMA P160049: Summary of safety and effectiveness data. Accessed January 2, 2026.
  7. Gouëffic Y. Quality of life outcomes Following treatment of femoropopliteal artery disease with paclitaxel‑coated balloons in a real‑world French population. Presented at: Paris Vascular Insights Course; December 13, 2025; Carrousel du Louvre, Paris, France.