Four-Year Data from the IN.PACT Global Study Highlight Durable Performance and Safety of IN.PACT™ Admiral™ DCB
November 05 2019 - 1:15PM
Medtronic plc (NYSE:MDT) today announced four-year data from
the IN.PACT Global study, which reinforce the long-term durability
and safety of the IN.PACT™ Admiral™ drug-coated balloon (DCB) in
patients with peripheral artery disease (PAD) in the superficial
femoral (SFA) and popliteal arteries. The data were presented this
morning in the late-breaking clinical trial session at the Vascular
Interventional Advances (VIVA) 2019 conference in Las Vegas.
Professor Thomas Zeller, M.D., director of
the Department of Angiology at Universitaets-Herzzentrum,
Freiburg-Bad Krozingen, Germany, presented the new, four-year
results from the full clinical cohort of the IN.PACT Global Study.
The results are the first four-year, real-world, fully adjudicated
DCB data to be presented in a scientific congress. IN.PACT Admiral
DCB demonstrated durable effectiveness and a strong safety profile
in a real-world population.
“The IN.PACT Global study is the largest
independently adjudicated real-world evaluation of any peripheral
intervention undertaken and includes patients with the most complex
lesions observed in any existing DCB clinical study, many of whom
have commonly known risk factors for progressive PAD,” said Prof.
Zeller. “Even in this real-world patient population, including
those with critical limb ischemia, we continue to see durable
treatment effect through four years. These data further demonstrate
the clinical benefit of IN.PACT Admiral DCB and its ability to be a
first-line therapy for patients with challenging lesions.”
Kaplan-Meier estimates demonstrated a freedom from
clinically-driven target lesion revascularization (CD-TLR) rate of
73.4% (n=1,406) in a large, real-world patient population through
4-years. Of the subjects enrolled, the mean lesion length was 12.09
± 9.54 cm, 18.0% had in-stent restenosis, 35.5% had occluded
lesions, 39.9% had diabetes, and 68.7% had calcified lesions.
Overall, the average time to first CD-TLRs in this complex patient
population was approximately 570 days.
Based on Kaplan-Meier estimate, IN.PACT Admiral
demonstrated a solid safety profile through four years with a low
major target limb amputation cumulative incidence of 1.1% through
four years. The freedom from all-cause death through four years was
83.5%, which is comparable to what would be expected in this
patient population.1 This rate is based on data from all
subjects enrolled in the IN.PACT Global study, among which 98% had
known vital status.
Furthermore, an additional analysis was conducted
to evaluate the performance of IN.PACT Admiral through four years
in patients with intermittent claudication and critical limb
ischemia (CLI) based on Rutherford Classification (RCC). The
Kaplan-Meier estimated freedom from CD-TLR was 74.5% (n=1,246) in
the intermittent claudication (RCC 2/3) patient cohort and 64.8%
(n=156) in the CLI (RCC 4/5) patient cohort respectively.
“The body of evidence on paclitaxel-coated devices
continues to mature with recent significant publications and
presentations, including the IN.PACT Global four year data, adding
to the totality of evidence generated,” said Mark Pacyna, vice
president and general manager of the Peripheral Vascular business,
which is part of the Cardiac and Vascular Group at Medtronic.
“Outcomes from the IN.PACT Global study specifically show that
IN.PACT Admiral DCB, which has now been used to treat approximately
500,000 patients worldwide, can prolong the time between
reinterventions in a very challenging patient population by over a
year and a half. Long-term and real-world data continue to
demonstrate both the safety of these devices and the overall
treatment benefit to the patient.”
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
About the IN.PACT Global StudyThe IN.PACT
Global Study is a prospective, single-arm study that has enrolled
over 1,500 patients across 24 countries, including the 1,406
patients in the full clinical cohort presented today, to
characterize the performance of the IN.PACT Admiral DCB in treating
real-world patients with challenging and complex lesions. The study
included adjudication of events by an independent clinical events
committee.
About MedtronicMedtronic plc
(www.medtronic.com), headquartered in Dublin, Ireland, is among the
world's largest medical technology, services and solutions
companies - alleviating pain, restoring health and extending life
for millions of people around the world. Medtronic employs more
than 90,000 people worldwide, serving physicians, hospitals and
patients in more than 150 countries. The company is focused on
collaborating with stakeholders around the world to take healthcare
Further, Together.
Any forward-looking statements are subject to
risks and uncertainties such as those described in Medtronic's
periodic reports on file with the Securities and Exchange
Commission. Actual results may differ materially from anticipated
results.
-end-
1 Caro J, Migliaccio-Walle K, Ishak KJ,
Proskorovsky I. The morbidity and mortality following a diagnosis
of peripheral arterial disease: long-term follow-up of a large
database. BMC Cardiovasc Disord 2005;5:14.
Julia FullerPublic Relations+1-707-210-2069
Ryan WeispfenningInvestor Relations+1-763-505-4626
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