Clinical Evidence Overview
IN.PACT Admiral Drug-Coated Balloon
Drug-Coated Balloons: A New Therapy for PAD in the Upper Leg
 Drug-coated balloons (DCBs) represent the newest minimally invasive treatment option available to
U.S. physicians who treat patients with peripheral artery disease (PAD) in the upper leg.
 DCBs offer a significant benefit compared to previously-available treatments such as percutaneous
transluminal angioplasty (PTA) and bare metal stents (BMS), which are associated with the common
need for repeat procedures due to recurrent symptoms related to the treated lesion. Additionally,
stents leave a permanent foreign implant in the vessel, limiting future treatment options.
 Supported by a robust body of evidence, the IN.PACT Admiral drug-coated balloon from Medtronic
has consistently demonstrated the best clinical outcomes of any existing medical technology for the
treatment of this common form of PAD, including the lowest reported rate of repeat procedures
(clinically-driven target lesion revascularization, or CD-TLR) and the highest reported rate of restored
blood flow (primary patency) at 12 months (per Kaplan-Meier Day 360 estimates), while minimizing
the need for durable implants (or stents).
Comparison of Repeat Procedure Rates
WEIGHTED AVERAGE OF 12-MONTH
REPEAT PROCEDURE RATES (TLR)
30.0%
*Averages based on published and available
studies. References available on pg. 2.
26.4%
25.0%
20.8%
20.0%
14.3%
15.0%
10.2%
10.0%
7.6%
5.0%
0.0%
Balloon (PTA)
1-7
Atherectomy
8-18
Bare Metal Stent
2-3, 19-26
Drug Eluting Stent
2-3, 19-26
IN.PACT Admiral DCB
7, 29
Qualitative Comparison for Illustration Purposes Only. Not Meant for Head-to-Head Comparison.
IN.PACT Admiral Clinical Program
The IN.PACT Admiral drug-coated balloon from Medtronic is the most studied DCB to date. The IN.PACT
Admiral clinical program includes ongoing studies involving more than 3,500 patients worldwide that
demonstrate positive, consistent results across a broad range of patient populations, both in real-world and
randomized controlled settings. Key studies that contributed to the U.S. Food and Drug Administration (FDA)
approval of IN.PACT Admiral include 12-month results from IN.PACT SFA Trial, as well as data from the postmarket IN.PACT Global Study. The results from the IN.PACT SFA Trial are unprecedented and suggest IN.PACT
Admiral as a new primary therapy in the treatment of PAD in the upper leg.
IN.PACT SFA Trial
 Randomized controlled trial designed to assess safety and efficacy of IN.PACT Admiral vs. PTA
 CD-TLR rates at 12 months were 2.4% for the DCB group compared to 20.6% for the PTA group
(p<0.001)
 Primary patency rates were 89.8% for the DCB group and 66.8% for the PTA group (p<0.001) based
on Kaplan-Meier survival estimates at 360 days
 Exceptional safety profile with a 95.7% primary safety composite*, combined with a low thrombosis
rate (1.4%), proving superior safety to PTA
* Defined as freedom from device-related and procedure-related death at 30 days and freedom from target limb
major amputation and CD-TVR at 12 months
1
Deeper Look at IN.PACT SFA Trial Patient
Population
A review of select baseline characteristics is
indicative of the high prevalence of co-morbidities
and complications commonly observed in patients
with PAD in the upper leg. These characteristics
further increase the risk of heart disease, heart
attack, stroke, and health complications related to
diabetes that are associated with this challengingto-treat condition.
Select Baseline
Characteristics
Age (years)
Male Gender
Diabetes
Hypertension
Coronary Artery Disease
Carotid Artery Disease
Current Smoker
IN.PACT SFA Trial
(n=220 IN.PACT
Admiral subjects)
67.5 ± 9.5
65.0% (143/220)
40.5% (89/220)
91.4% (201/220)
57.0% (122/214)
34.9% (73/209)
38.6% (85/220)
IN.PACT Global Study
 Largest post-market registry of its kind designed to assess safety and efficacy of the IN.PACT Admiral
in real-world clinical practice
 Reproducible, positive outcomes were observed in this study, which included patients with more
complex disease and more challenging lesions
 Results from the first 655 patients treated in IN.PACT Global include a 12-month CD-TLR rate of
8.7%, which validate the findings from IN.PACT SFA
 The data reinforce strong safety of IN.PACT Admiral, with an 89.6% primary safety composite*, and
low thrombosis rate (3.8%)
* Defined as freedom from device-related and procedure-related death at 30 days and freedom from target limb
major amputation and CD-TVR at 12 months
Chart References
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