Medtronic RESOLUTE ONYX(TM) 2.0 mm Clinical Study Meets Primary Endpoint in Extra-Small Vessels at One-Year
18 May 2017 - 4:30PM
First-Ever Study
on 2.0 mm DES, EuroPCR Late-Breaking Data Show Exceptional
Deliverability and No Stent Thrombosis for the Resolute Onyx
DES
DUBLIN and PARIS- May 18, 2017
- Medtronic plc (NYSE: MDT) today announced that the Resolute
Onyx(TM) Drug-Eluting Stent (DES) met its primary endpoint of
Target Lesion Failure (TLF) at one year for the treatment of
coronary artery disease in extra-small vessels. Results from the
RESOLUTE ONYX 2.0 mm Clinical Study were presented today as a Hot
Line/Late-Breaking Trial Session at the 2017 EuroPCR Annual Meeting
and simultaneously published in the Journal of the
American College of Cardiology (JACC): Cardiovascular
Intervention.
It is estimated that approximately 65 percent of
extra-small vessels are located in critical locations of the heart,
making them significant lesions to treat.1 Designed
specifically for extra-small vessels, Resolute Onyx 2.0 mm DES
yielded excellent clinical outcomes in the study compared to a
pre-specified performance goal with patients experiencing
significantly low rates of TLF at one year (5.0 percent, p<=0.001). The study enrolled
101 patients with extra-small vessel sizes (2.0 mm - 2.25 mm) who
received the Resolute Onyx 2.0 mm diameter DES across 20 sites in
the United States and Japan.
"Treating coronary disease in extremely small
arteries presents a real clinical challenge, as these lesions tend
to be located in difficult-to-reach areas of the heart, have
greater restenosis rates, and until now, we lacked the right stents
to treat them safely and successfully," said Matthew J. Price,
M.D., interventional cardiologist at Scripps Clinic in La Jolla,
Calif. and principal investigator of the RESOLUTE ONYX 2.0 mm
Clinical Study who presented the one-year data at EuroPCR. "The
excellent clinical performance we observed demonstrates the
importance of designing stents like the Resolute Onyx DES that
address a relevant unmet need. Thinner struts with enhanced
radiopacity and a lower crossing profile provide excellent
deliverability, and the stent can be over-expanded to treat
tapered, challenging lesions."
In the study, the events included in the TLF
primary endpoint were low at one-year, as defined by low
target-vessel MI (3 percent), low target lesion revascularization
(2 percent) and no cardiac death. Additionally, Resolute Onyx DES
showed no stent thrombosis.
The Resolute Onyx DES is the first and only DES to
feature Core Wire Technology, an evolution of Continuous Sinusoid
Technology (CST). CST is a unique Medtronic method of stent
manufacturing, which involves forming a single strand of cobalt
alloy wire into a sinusoidal wave to construct a stent. This
enables greater deliverability and conformability to the vessel
wall. With Core Wire Technology, a radiopaque inner core is
incorporated within the cobalt alloy wire to enhance visibility for
accurate stent placement. Core Wire Technology also enables thinner
struts while maintaining structural strength.
"The RESOLUTE ONYX 2.0 mm Clinical Study builds on
the positive body of evidence supporting the clinical performance
of the Resolute Onyx stent," said Jason Weidman, vice president and
general manager of the Coronary and Renal Denervation business,
which is part of the Cardiac and Vascular Group at Medtronic.
"These initial results reinforce the unique design of the Resolute
Onyx, providing physicians and patients around the globe with the
gold standard in drug-eluting stents."
The Resolute Onyx 2.0 mm diameter DES are for
investigational use only in the United States. The Resolute Onyx
DES received approval by the Food and Drug Administration (FDA) in
April 2017 and is now available for use in the United States for a
broad range of sizes from 2.25 mm - 5.0 mm. It is also approved for
use in Europe and other countries that recognize the CE (Conformité Européene) Mark.
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 88,000 people worldwide, serving physicians,
hospitals and patients in more than 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 Schunkert
et al. JACC July 1999
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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