YASTEST
Data Further
Reinforce IN.PACT Admiral DCB as Frontline
Option to Address Treatment Challenges in PAD
DUBLIN and LAS VEGAS - September
12, 2017 - Medtronic plc (NYSE: MDT) data announced today
reinforce the durability and safety of the IN.PACT(TM) Admiral(TM)
drug-coated balloon (DCB) in patients with peripheral arterial
disease (PAD). The two-year, real-world results from the full
clinical cohort of the IN.PACT Global Study and four-year results
from the pivotal IN.PACT SFA Study were presented in two
late-breaking clinical trial presentations at the Vascular
Interventional Advances (VIVA) 2017 conference in Las Vegas.
IN.PACT Global
Study
Professor Thomas Zeller, M.D., director of the Department of
Angiology at Universitaets-Herzzentrum, Freiburg-Bad Krozingen,
Germany, presented the new, two-year results from the full clinical
cohort of the IN.PACT Admiral DCB Global Study. The results are the
first two-year, real-world, fully adjudicated DCB data to be
presented in a scientific congress, which showed consistent
performance in both safety and efficacy for IN.PACT Admiral
DCB.
The data were calculated using Kaplan-Meier
survival estimates and revealed a freedom from clinically-driven
target lesion revascularization (CD-TLR) rate of 83.3 percent in a
real-world patient cohort with a mean lesion length of 12.09 ± 9.54
cm, 18.0 percent in-stent restenosis lesions, 35.5 percent occluded
lesions and 39.9 percent diabetes subjects. Additional safety and
effectiveness outcomes also included low rates of thrombosis (4.5
percent), occurrences of major target limb amputation (0.7
percent), and CD-TLR (16.9 percent) within two years.
"At two years, the IN.PACT Admiral DCB continues
to confirm positive outcomes from the IN.PACT randomized trials,
demonstrating efficacy, safety, and durability, despite the
complexity of these lesions," said Prof. Zeller. "These results
also highlight the clinical utility of the IN.PACT Admiral DCB as a
primary therapy in treating patients with some of the most
challenging PAD cases."
The IN.PACT Global Study is the largest
and most rigorous real-world evaluation of any peripheral artery
intervention ever undertaken. It 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.
IN.PACT SFA Study
Dr. Peter Schneider, chief of the vascular therapy division at
Kaiser Foundation Hospital and Hawaii Permanente Medical Group in
Honolulu also presented the first, four-year data outcomes for a
DCB, further demonstrating the safety and efficacy of IN.PACT
Admiral DCB in patients with PAD. Of the patients who received a
repeat procedure within four years, those in the IN.PACT Admiral
DCB group showed that time to reintervention was approximately
double that of those in the percutaneous transluminal angioplasty
(PTA) group (739.2 ± 384.0 days for IN.PACT Admiral DCB on average
versus 302.9 ± 213.0 days for PTA (p<0.001)).
Using Kaplan-Meier survival rate estimates,
IN.PACT Admiral DCB continued to outperform in freedom from CD-TLR
compared to PTA with a 76.8 percent compared to 70.4 in PTA (p=
0.0399). The data also showed the long-term safety benefits of the
IN.PACT Admiral DCB, with no major target limb amputations, a low
rate of thrombosis, and no major adverse events from years three to
four in the IN.PACT Admiral DCB group.
"With the IN.PACT Admiral DCB, pre-clinical
studies have demonstrated that the drug remains in the tissue for
approximately six months. Therefore, at four years, we would expect
to see some catch up effect and at least some late progression of
atherosclerosis," said Dr. Schneider. "However, in the four-year
data from IN.PACT SFA, we are still seeing sustained durability and
clinical benefit. For patients suffering with this chronic
condition, these findings are not only encouraging from a
therapeutic perspective, but are also suggestive of improved
quality of life, with patients requiring fewer reinterventions over
time compared to PTA and leaving future treatment options
open."
The IN.PACT SFA Trial enrolled 331 patients at 57
sites across Europe and the United States who were randomized to
treatment with either the IN.PACT Admiral DCB or PTA. The four-year
data includes a total of 284 patients (184 DCB and 103 PTA).
"PAD is a chronic condition associated with
disease progression and often requires repeat interventions to
manage the disease," said Mark Pacyna, vice president and general
manager of the Peripheral business in the Medtronic Cardiac &
Vascular Group. "In partnership with the clinical community, our
objective has been to develop a safe, effective, and sustainable
treatment option for these patients. The data presented today
reflects this goal and our commitment to timely and transparent
data releases. We are excited to see consistency in real-world
patients and fewer interventions out to four years, which was
statistically significant."
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. It was the first DCB to have received
approval by the U.S. Food and Drug Administration (FDA) for the
treatment of in-stent restenosis. The DCB's primary mode of action
is physical dilatation of the vessel lumen by PTA, and the proven
paclitaxel drug, with a unique dose and excipient, is intended to
prevent artery narrowing by minimizing scar tissue formation.
IN.PACT Admiral DCB received the CE (Conformité Européene) Mark in 2009 to treat PAD and was
approved by the FDA in December 2014 to treat superficial femoral
and popliteal arteries. It has been studied in more than 20
individual clinical trials demonstrating durable safety and
clinical benefits. To date, approximately 200,000 patients have
been treated with IN.PACT Admiral DCB. It is the only DCB to have
published two-year data from a pivotal randomized trial, as well as
the first to have presented three- and four-year data.
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 84,000 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:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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