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IN.PACT Admiral 5-Year Reintervention Data

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Tested. Trusted. Market-leading drug-coated balloon


75% of patients treated with IN.PACT™ Admiral™ Paclitaxel-coated
PTA Balloon Catheter remain reintervention-free at 5 years1
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Alert Indications, Safety, and Warnings

Long-term outcomes

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter continues to demonstrate long-term clinical outcomes, even in patients considered to be at high risk of restenosis and repeat interventions.

 

Freedom from CD-TLR through 5 years:

  • 74.5% IN.PACT SFA Trial1
  • 58.0% IN.PACT Global ISR Cohort2
  • 67.3% IN.PACT Global Long Lesion Cohort2
  • 69.8% IN.PACT Global CTO Cohort2
IN.PACTTM AdmiralTM Trials

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IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter has the:

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Highest

patency benefit through 3 years compared to PTA†1

Most

publication for a DCB‡

Proven formulation

The IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter features a proprietary FreePac™ coating solution that allows for the release of drug into the tissue through the restenotic window.
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Duration of paclitaxel in tissue

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter provides 180 days of drug in tissue.§3
pta ballon

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We have extended our DCB range

Introducing new longer lengths to our IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter range, to give you more options for treatment of longer, complex lesions. 
Clinical performance
  • Highest primary patency7 91.1%8
  • Mean Lesion length 26cm
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dcb-range

Impacting patient care

Watch Dr. Ehrin Armstrong speak about the benefits and clinical evidence to support IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter as his DCB of choice.
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Meet Robert Canterbury, who was diagnosed with peripheral artery disease (PAD), and see how IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheterhelped get him back on his feet.
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Additional resources

One proven formulation, two platforms for SFA treatment.

With 0.035” and 0.018” guidewire compatibility.

More information

Related resources



Lifeline cardiovascular technical support

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rs.cstechsupport@medtronic.com

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*Third-party brands are trademarks of their respective owners.
**Based on sales units sold since commercialization. Units sold divided by units per procedure.
† Primary patency not assessed after three years.
‡ Data on file UC202013694cEE at Medtronic. https://europe.medtronic.com/content/dam/medtronic-com/xd-en/hcp/documents/digitalhub/cardiovascular/pvh/going-long-dcb/DCB_landscape_revision.pdf
§ Data comes from different individual studies and may differ in a head-to-head comparison, and therefore may not be predictive of clinical results.

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

FDA. PMA P140010: Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140010(opens new window). Accessed May 10, 2022.

4

FDA. PMA P190019: FDA Summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190019(opens new window). Accessed May 10, 2022.

5

Virmani R. 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

FDA. PMA P160049: FDA summary of safety and effectiveness data. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160049(opens new window). Accessed May 10, 2022.

7

Based on clinical data for drug-coated balloons indicated to treat long SFA lesions (>180 mm): compared to Lutonix™* IFU BAW1387400r3. Per Stellarex™* IFU P011966-B, Stellarex is not indicated to treat lesions longer than 180 mm. Definitions of patency and lesion length may vary for different studies.

8

The IN.PACT Global Study Long Lesion Imaging Cohort D. Scheinert Circulation 2018.

9

Granada JF, Stenoien M, Buszman PP, et al. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart. August 6, 2014;1(1):e000117.