IN.Pact Admiral Long Balloon Hero Image

GOING TO
GREATER
LENGTHS
TO TREAT
COMPLEX
LESIONS


IN.PACT Admiral
Drug-Coated Balloon (DCB)

NOW AVAILABLE IN 200 MM and
250 mm Sizes

The IN.PACT Admiral DCB allows you to treat long, complex lesions with longer balloon lengths,
which helps reduce procedure
time and costs.

IN.Pact Admiral Long Balloon Treatment Illustration

IN.PACT Global Study ANALYSIS DESIGN*

The objective from the IN.PACT Global Study was to assess the safety and effectiveness of the IN.PACT Admiral DCB in the treatment of long lesions in the superficial femoral and popliteal arteries.

A total of 227 DCB subjects with lesion lengths > 180 mm and Rutherford clinical category 2-4 comprised the complex lesion cohort.

The mean lesion length was 28.74 ± 7.11 cm with 70.1% total occlusions and 20.4% in-stent restenotic lesions.

IN.Pact Admiral Long Balloon Analysis Design Illustration

RESULTS

Primary patency per Kaplan-Meier Analysis at 12 months was 89.1% for all subjects.

LEARN MORE ABOUT THE
CLINICAL DATA
IN.Pact Admiral Long Balloon Study Results Line Graph
IN.Pact Admiral Long Balloon Performance Bar Chart

PERFORMANCE IN LONG LESIONS

Competitive comparison

Learn about the Science
behind the Outcomes

EXTEND YOUR EXPECTATIONS

The IN.PACT Admiral DCB has the LONGEST LESION INDICATION (360 mm)6 supported by the HIGHEST PRIMARY PATENCY. 7

GET TECHNICAL SPECIFICATIONS
IN.Pact Admiral Long Balloon Spec Graphic

*

The analysis was performed on the subjects enrolled in the IN.PACT Global Imaging Cohorts. Additional information on the IN.PACT Global Study can be found here.


References

1

IN.PACT Admiral IFU M052624T001. Primary patency is defined as freedom from core laboratory-assessed restenosis (duplex ultrasound PSVR ≤ 2.4) or clinically-driven target lesion revascularization through 12 months (adjudicated by a clinical events committee blinded to the assigned treatment). Patency per Kaplan-Meier estimates at 12 months (provisional stent rate of 42.5%).

2

IN.PACT Admiral IFU M052624T001 Rev. 1G, Primary patency is defined as freedom from core laboratory-assessed restenosis (duplex ultrasound PSVR ≤ 2.4) or clinically-driven target lesion revascularization through 12 months (adjudicated by a clinical events committee blinded to the assigned treatment). Patency per Kaplan-Meier estimates at 12 months (day 360).

3

Lutonix IFU BAW1387400r4, Primary patency is defined as freedom from CEC-adjudicated clinically-driven TLR and from core-lab adjudicated binary restenosis. Patency per Kaplan-Meier estimates at 12 months (day 365).

4

IN.PACT Admiral IFU M052624T001 Rev. 1G.

5

Lutonix IFU BAW1387400r4 — Table 33: Procedural Data (Bailout Spot Stent Used Post-DCB Dilatation).

6

IN.PACT Admiral IFU M052624T001 compared to Lutonix™* IFU BAW1387400r4 and Stellarex™* IFU P011966-B.

7

Based on clinical data for drug-coated balloons indicated to treat long SFA lesions (> 180 mm): compared to Lutonix™* IFU BAW1387400r4. 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. Note: Results are from different clinical studies and may differ in a head-to-head comparison.

 

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