New Rigorous
Analyses Presented at Charing Cross Reinforce Efficacy in Females,
Chronic Total Occlusions and Patients with Diabetes; Data Details
Unique, Sustained Benefit with IN.PACT Admiral DCB
DUBLIN and LONDON - April 26,
2016 - Medtronic plc (NYSE: MDT) today added to its robust body
of clinical evidence supporting the IN.PACTTM
AdmiralTM drug-coated
balloon (DCB) with several new presentations that showed durable
and consistent clinical outcomes in the most challenging patients
with peripheral artery disease (PAD). The new data, presented at
the 2016 Charing Cross Symposium in London, included the one-year
results from the chronic total occlusion imaging cohort from the
IN.PACT Global Study and the two-year gender and diabetic subgroup
analyses from the pivotal IN.PACT SFA Trial.
"The IN.PACT Admiral drug-coated balloon's unique
coating delivers paclitaxel in a solid state which results in
durable tissue levels of drug leading to prolonged anti-restenotic
effect. We have first-of-its-kind data that shows it continues to
do so even in the more challenging cases and patient populations,"
said Peter Schneider, M.D., of Kaiser Medical Center in Honolulu,
and a principal investigator of the IN.PACT SFA Trial. "These data
continue to position the IN.PACT Admiral drug- coated balloon as a
durable treatment option for femoropopliteal interventions."
CHRONIC TOTAL OCCLUSION
ANALYSIS
New data from the chronic total occlusion (CTO) imaging cohort of
the real-world, IN.PACT Global Study were presented today at
Charing Cross by Gunnar Tepe, M.D., chief of radiology at RoMed
Klinikum in Rosenheim, Germany. CTOs are typically characterized by
calcified plaque, which often result in complete (or nearly
complete) obstruction of blood flow through the artery.
As part of the 1,535 patients enrolled across 27
countries in the rigorous, first-of-its-kind IN.PACT Global Study,
126 patients with an average lesion length of 22.9 cm were included
in the pure CTO imaging cohort analysis. The primary patency rate
was 84.4 percent and the clinically-driven target lesion
revascularization (CD-TLR) rate was 12.2 percent at one year.
Additional safety and efficacy outcomes included low rates of
all-cause mortality (4.3 percent), thrombosis (4.3 percent) and no
occurrences of major target limb amputation (0.0 percent). Previous
reports from the IN.PACT Global Study demonstrated effectiveness in
complex in-stent restenosis (ISR) lesions and long lesions in the
SFA through one year.
"Despite the complexity of these challenging and
complex long chronic total occlusion lesions, the outcomes were
excellent and remarkably consistent to that of the overall cohort.
These results show the effectiveness of the IN.PACT Admiral
drug-coated balloon as a primary treatment in this complex lesion
subset," concluded Dr. Tepe.
GENDER AND DIABETES
ANALYSIS
IN.PACT SFA Trial investigators sought to better understand the
treatment effect of the IN.PACT Admiral DCB compared to balloon
angioplasty in females and patients with diabetes, patient
populations whose outcomes have historically not fared as well as
males and non-diabetic patients, respectively. Dr. Schneider
presented outcomes from the IN.PACT SFA Trial gender and diabetes
subgroups, which showed superior and durable outcomes for the
IN.PACT Admiral DCB compared to balloon angioplasty across both
subgroups at two years.
The IN.PACT SFA Trial enrolled 331 patients, 113
of which were female, at 57 sites across Europe and the United
States. At two years, females who were treated with the IN.PACT
Admiral DCB demonstrated a higher primary patency rate compared to
balloon angioplasty arm (76.7 percent versus 42.3 percent,
p<0.001). Similarly, females in the IN.PACT Admiral DCB arm had
a lower CD-TLR rate compared to the balloon angioplasty arm (13.2
percent versus 38.2 percent, p=0.005). The beneficial treatment
effect seen in female patients who were treated with the IN.PACT
Admiral DCB was consistent with the male population, who had a
primary patency rate of 80.2 percent in the IN.PACT Admiral DCB
arm, compared to 53.7 percent in the balloon angioplasty arm
(p<0.001), and a 6.9 percent CD-TLR rate versus 23.6 percent
(p=0.002), respectively. These positive DCB outcomes in the female
population are unique to IN.PACT Admiral DCB.
In a separate evaluation of patients with or
without diabetes, the IN.PACT Admiral DCB group continued to
demonstrate consistently favorable results at two years regardless
of whether a patient had diabetes. Among patients with diabetes,
those treated with an IN.PACT Admiral DCB had significantly higher
rates of primary patency (73.3 percent versus 45.8 percent,
p<0.001) and CD-TLR (10.7 percent versus 29.4 percent, p=0.010)
compared to balloon angioplasty. Similarly, in the non-diabetes
subgroup, the IN.PACT Admiral DCB arm showed consistent and
significant improvements in primary patency (82.5 percent versus
54.5 percent, p<0.001) and CD-TLR (8.1 percent versus 27.3
percent, p=0.002).
DATA CONFIRMS IN.PACT ADMIRAL DCB
CLINICAL BENEFIT
These sustained and consistent results across complex anatomy and
patient subsets may be partly attributed to IN.PACT Admiral DCB's
unique coating. New pre-clinical data presented at Charing
Cross today by Renu Virmani, M.D., a cardiovascular pathologist and
president of CVPATH Institute in Gaithersburg, Md., demonstrated
that IN.PACT Admiral DCB's proprietary coating demonstrates
sustained paclitaxel in tissue over time, facilitating an extended
retention of drug in tissue available for a sustained
anti-restenotic effect.
"The rigor, volume and cadence of strong clinical
data along with the consistency of data for the IN.PACT Admiral
drug-coated balloon are among the best for any anti-restenotic
therapy available for the treatment of symptomatic superficial
femoral artery disease," said Dr. Mark Turco, medical director of
the Aortic & Peripheral Vascular Business within Medtronic's
Cardiac and Vascular Group. "When evaluating quality of study data,
it's important to consider the clinical rigor built into the study
design. This is why Medtronic has made a significant investment in
rigorous independent core lab adjudication for the IN.PACT clinical
program to deliver unquestionable results. "
About IN.PACT Admiral Drug-Coated
Balloon
The IN.PACT Admiral drug-coated balloon is a clinically-proven,
cost-effective primary endovascular therapy that enables physicians
to treat claudication, and restenosis for patients with superficial
femoral artery (SFA) disease. The DCB's primary mode of action is
physical dilatation of the vessel lumen by percutaneous
transluminal angioplasty (PTA), and the proven paclitaxel drug is
intended to prevent artery narrowing by minimizing scar tissue
formation. See how it works, click here.
IN.PACT Admiral DCB received the CE (Conformité
Européene) Mark in 2009 to treat peripheral artery disease (PAD)
and was approval by the U.S. Food & Drug Administration in
December 2014 to treat superficial femoral and popliteal arteries.
In 2016, the CE Mark indication was expanded for the treatment of
failing arteriovenous (AV) access in patients with end-stage renal
disease undergoing dialysis. It has been studied in more than 20
individual clinical trials demonstrating durable safety and
clinical benefits. To date, more than 100,000 patients have been
treated with IN.PACT Admiral DCB. See:
www.Medtronic.com/dcbresultsCX
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 Medtronic
Medtronic 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 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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-
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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