Multiple, Rigorous
Analyses Reinforce the Excellent Outcomes of IN.PACT Admiral Drug
Coated Balloon and Differentiate it as Best-in-Class Treatment
Option for PAD
DUBLIN and LAS VEGAS - September
19, 2016 - Medtronic today reinforced the superior durability,
consistency, and safety of the IN.PACT Admiral drug-coated balloon
(DCB) in patients with peripheral arterial disease (PAD). The new
data, presented in a series of late-breaking clinical trial
presentations at the Vascular Interventional Advances (VIVA) 2016
conference in Las Vegas, included three-year results from the
pivotal IN.PACT SFA Trial and one-year, real-world results from the
full clinical cohort of the IN.PACT Global Study.
IN.PACT SFA Trial
The three-year outcomes from the IN.PACT SFA Trial
were presented today by Prakash Krishnan, M.D., assistant professor
of medicine and director of endovascular intervention at Mount
Sinai Heart in New York. The results demonstrated the sustained,
long-term clinical benefits of IN.PACT Admiral DCB compared to
plain balloon angioplasty.
"The IN.PACT Admiral is the only DCB to-date with
superior performance supported by three-year data," said Dr.
Krishnan. "In line with the one- and two-year data, we saw a
consistently low clinically-driven target lesion revascularization
rate and high patency rate. These durable, long-term outcomes
reinforce the shift we are seeing in adoption of IN.PACT Admiral
DCB as the primary treatment option for SFA treatment."
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 plain balloon
angioplasty (percutaneous transluminal angioplasty, or PTA). The
data demonstrate strong durability through three years with
superior performance in both primary patency (69.5 percent compared
to 45.1 percent in the PTA group (p<0.001)) and
clinically-driven target lesion revascularization (CD-TLR) (15.2
percent compared to 31.1 percent in the PTA group (p=0.002)).
Additionally, of the patients who received a
repeat procedure within three years, those in the IN.PACT Admiral
DCB group did not require a second procedure as soon as those in
the PTA group (542.9 days for IN.PACT Admiral DCB on average versus
302.9 days for PTA, p<0.001). The data also continue to
demonstrate the long-term safety benefits of the IN.PACT Admiral
DCB, with no major target limb amputations in the IN.PACT Admiral
DCB group.
IN.PACT Global Study
In a separate session, Michael R. Jaff, D.O.,
medical director, Mass General Vascular Center at the Massachusetts
General Hospital and professor of medicine at Harvard Medical
School in Boston, presented new one-year results from the full
clinical cohort of the IN.PACT Global Study. The results continue
to underscore the consistent performance in both safety and
efficacy for the IN.PACT Admiral DCB.
The IN.PACT Global Study is the largest
and most rigorous post-market evaluation of any peripheral artery
intervention ever undertaken. It has enrolled over 1,500 patients
across 27 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 external
monitoring and adjudication of events by an independent clinical
events committee. Additionally, it included core lab evaluations
for pre-specified imaging subsets for subjects with long lesions
(>=15 cm) (n=157), chronic total occlusions (CTO) (>= 5 cm)
(n=126) and in-stent restenosis (ISR) lesions (n=131), as recently
presented at international conferences.
"Despite the complexity of these challenging
lesions and patients, the outcomes were consistent across all
patients, including the imaging subsets," said Dr. Jaff. "Complex
lesion types, including long lesions, chronic total occlusions and
ISR, remain challenging to treat with no clearly superior treatment
options. These results demonstrate the effectiveness of the IN.PACT
Admiral DCB as a primary therapy in treating these challenging
patients who we routinely see in clinical practice."
The one-year data demonstrated a low CD-TLR rate
of 7.5 percent in a population with a mean lesion length of 12.09
cm, 18.0 percent in-stent restenosis lesions, and 35.5 percent
occluded lesions. Additional safety and efficacy outcomes also
included low rates of thrombosis (2.9 percent), occurrences of
major target limb amputation (0.2 percent), and clinically-driven
target vessel revascularization (8.1 percent) within one year.
"When evaluating quality of data, it's important
to consider the clinical rigor built into the study design," said
Mark Turco, M.D., medical director of the Aortic & Peripheral
Vascular Business within Medtronic's Cardiac and Vascular Group.
"This is why Medtronic has made significant investments in
independent adjudication for the IN.PACT clinical program to
deliver unquestionable results that clinicians have come to expect
in our DCB. The three-year IN.PACT SFA data and the one-year
IN.PACT Global data continue to demonstrate consistency,
durability, and safety of the IN.PACT Admiral DCB. We look forward
to sharing additional outcomes when other data sets mature."
IN.PACT DEB Long
Study
Additionally, Dr. Antonio Micari of Maria Eleonora Hospital in
Palermo, Italy performed an independent study evaluating treatment
of long lesion lengths with the IN.PACT Admiral DCB. His data will
be presented in the late-breaking clinical trial session at VIVA on
Tuesday, September 20, 2016.
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 is the
only 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 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, more than 150,000 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 and also
the first to have presented three 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 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-
Contacts:
Krystin Hayward
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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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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