First Drug-Coated Balloon (DCB) Study Results in Japan Demonstrate Consistent Clinical Outcomes with Other Medtronic DCB Stud...
February 09 2017 - 8:00AM
New Data Recently
Presented at LINC 2017 Represents the First
Presentation of Clinical Results Comparing a DCB to Angioplasty in
Japan
DUBLIN -
Feb. 9, 2017 - Medtronic plc (NYSE: MDT) today announced the
one-year clinical outcomes from the MDT-2113 IN.PACT SFA Japan
Trial. The data was recently presented by Osamu Iida, M.D., Kansai
Rosai Hospital, Hyogo, Japan at the Leipzig Interventional Course
(LINC) 2017 conference, and reinforced the consistent clinical
outcomes obtained using Medtronic's drug-coated balloon (DCB).
The IN.PACT SFA Japan Trial enrolled 100 patients
at 11 sites in Japan who were randomized to treatment with either
the DCB (n=68) or plain balloon angioplasty (percutaneous
transluminal angioplasty, or PTA) (n=32). Per protocol, primary
patency rates were assessed at 12 months of follow-up and
demonstrated: 89.2 percent for the DCB group and 48.4 percent for
the PTA group (p<0.001). Primary patency at 360 days was also
calculated by Kaplan-Meier survival estimates; at this specific
time point, it was 93.9 percent for the DCB group and 49.9 percent
for the PTA group (p<0.001). Primary patency means a restoration
of adequate blood flow through the treated segment of the diseased
artery. Clinically-driven target lesion revascularization was 2.9
percent for the DCB group, compared to 18.8 percent in the PTA
group (p=0.012).
The data also showed lower major adverse events
for the DCB at one year (4.4 percent compared to 18.8 percent in
the PTA group; p=0.028), with no major target limb amputations.
"This study builds on the previous Medtronic DCB
clinical studies, reinforcing the consistent clinical performance
in terms of primary patency and re-intervention rates of this
device across patient populations," said Dr. Iida. "We are pleased
to see such substantive DCB clinical data from a patient cohort in
Japan."
These results are consistent with prior findings
from the pivotal IN.PACT SFA Trial one-year outcomes, and further
reinforce the real-world results from the full clinical cohort of
the IN.PACT Global Study.
"The MDT-2113 IN.PACT SFA Japan Trial represents
our global commitment to deliver robust clinical evidence to aid in
the choice of treatment options for patients with PAD," said Mark
Pacyna, vice president and general manager of the Peripheral
business, which is part of the Cardiac and Vascular Group at
Medtronic. "We are pleased to be the first to present data
comparing a DCB to angioplasty in Japan."
The Medtronic DCB is an investigational device in
Japan and not available for sale.
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 Leong
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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