Medtronic Drug-Coated Balloon (DCB) Demonstrates Consistent Results in Two New Analyses of Complex PAD Patients
April 25 2017 - 6:30AM
DUBLIN and LONDON - April 25,
2017 - Medtronic plc (NYSE: MDT) today reinforced consistent
results for its IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB)
with two new sub-analyses from the IN.PACT Global Study in patients
with peripheral artery disease (PAD). The new data were reported at
the annual 2017 Charing Cross Symposium (CX) in London, one of the
world's largest educational meetings specializing in vascular and
endovascular disease management.
Sub-Analysis in Patients with
Complex Lesions
In a "Podium First" presentation at the conference, Gary Ansel,
M.D., system medical director for Vascular Services at OhioHealth
Riverside Methodist Hospital in Columbus, Ohio, presented one-year
results analyzing outcomes in patients from the IN.PACT Global
Study with complex lesions. The analysis compared standard usage
patients (n=281) who met similar inclusion criteria for the IN.PACT
SFA pivotal trial,1 an
investigational device exemption (IDE) study, compared with use in
a broader spectrum of patients (n=1125) who had wider inclusion
criteria reflecting more real-world patients.2
Results in both groups demonstrated consistent and
positive outcomes with IN.PACT Admiral at one year. In the standard
IN.PACT Global Study group, clinically-driven target lesion
revascularization (CD-TLR) was 3.4 percent, which was comparable to
2.4 percent in a similar population in the IN.PACT SFA pivotal
trial. CD-TLR for the group with complex lesions was 8.5 percent,
despite the disease complexity observed in these patient types.
These results were also consistent with the full clinical cohort
for the IN.PACT Global Study (n=1406), in which one-year CD-TLR was
7.5 percent.
Results of the primary safety endpoint were
generally consistent across the cohorts and no safety signals were
observed.
"These sub-analyses show that IN.PACT Admiral
continues to deliver durable and consistent results across our more
typically treated patient populations," commented Dr. Ansel.
"Notably, the data in this study highlight that the IN.PACT Admiral
DCB can be safe and effective when used in our patients with
complex PAD, such as those with challenging calcified lesions and
with significant co-morbidities."
Sub-Analysis of Patients with
Calcified Lesions
Additionally, Fabrizio Fanelli, M.D., EBIR, professor of radiology
at the Sapienza University in Rome, Italy, shared results of a new
subset analysis of patients with complex, calcified lesions from
the long lesion and chronic total occlusion (CTO) imaging cohort of
the IN.PACT Global Study.
The analysis included long lesion and CTO patients
defined as having moderately severe or severely calcified lesions
(n=72).3 Calcium
levels were assessed by the site according to protocol and
confirmed by core laboratory assessment. At one year, patients
achieved primary patency rates of 88.8 percent as calculated by
Kaplan-Meier analysis. Primary patency is the ability for the
treated artery to remain open over time. The analysis also
demonstrated a CD-TLR rate of 8.5 percent. Consistent with other
data sets, no safety signals were observed. In 51.4 percent of
subjects, provisional stenting occurred.
Calcium remains a challenge within endovascular
procedures and has historically been linked to higher provisional
stenting rates, greater complications and poor outcomes.
Directional atherectomy and specialty balloons, while not evaluated
in this study, are commonly used to debulk or predictably dilate
calcified lesions, which may minimize the need for provisional
stents.4
"Through our investments in the IN.PACT clinical
program and ongoing studies, Medtronic is committed to partnering
with clinicians to develop evidence-based treatments for complex
PAD," said Mark Pacyna, general manager of the Peripheral business,
which is part of Medtronic's Aortic & Peripheral Vascular
division. "The adoption of IN.PACT Admiral as a frontline treatment
option has been driven by its unparalleled clinical profile, which
continues to demonstrate durability, safety, and efficacy across
PAD patient populations."
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 of the highest quality that deliver clinical and economic
value to healthcare consumers and providers around the world.
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
femoropopliteal disease. It has been studied in 21 individual
clinical trials demonstrating durable safety and clinical benefits.
To date, more than 200,000 patients have been treated with the
IN.PACT Admiral DCB.
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 88,000 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-
1 Patients
with single lesions less than or equal to 18 cms, total occlusions
less than or equal to 10 cms, no in-stent restenosis (ISR), and
none to mild calcification.
2 Patients
with bilateral/multiple lesions, and moderate-to-severe
calcification.
3 Dattilo,
R; J Invasive Cardiol 2014;26(8):355360.
4 McKinsey,
J. F., et al. (2014). JACC Cardiovasc Interv 7(8): 923-933.
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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