Medtronic Initiates Pivotal Studies of Resolute Onyx(TM) Drug-Eluting Stent in United States
March 12 2015 - 9:30AM
Next-Generation
Device with CoreWire Technology to be Studied in Wide Spectrum of
Patients, Including the Smallest Coronary Arteries
DUBLIN - March 12, 2015 - Medtronic plc (NYSE: MDT) today
announced the start of its Resolute Onyx(TM) Clinical
Program in the United States, which will evaluate the Resolute
Onyx(TM) drug-eluting
stent (DES) in patients who have coronary artery
disease. Included in the first phase of the study are
patients with small vessels that would require a 2.0 mm stent,
which until now, often were untreatable with a DES. Core sizes of
the stent will be studied separately.
"One of the biggest challenges we face as
interventional cardiologists is treating small, diseased coronary
arteries - a common condition seen frequently in patients with
diabetes," said Roxana Mehran, M.D., cardiologist and professor of
medicine at Mount Sinai School of Medicine in New York City, and
principal investigator for the study. "The trial initiation of the
Resolute Onyx DES with CoreWire Technology is an exciting step
forward in providing a treatment option for difficult-to-treat
coronary lesions."
Built on the proven clinical performance and
superior deliverability of the Resolute Integrity DES, the Resolute
Onyx DES features CoreWire Technology that allows it to have a
denser core metal surrounded by a cobalt alloy outer layer. The new
technology not only enables the stent to have better radiopacity
(visibility) during the procedure, but with thinner struts, the
stent is designed to help improve deliverability without
compromising radial and longitudinal strength, all of which help
improve the efficiency of procedures.
CoreWire Technology builds on Continuous Sinusoid
Technology (CST), a method of stent manufacturing first introduced
with the Resolute Integrity DES, which molds one single strand of
wire into a sinusoidal wave enabling a continuous range of
motion.
"CoreWire Technology represents a new foundation
for drug-eluting stent innovation that optimizes the treatment of
coronary artery disease," said Jason Weidman, vice president and
general manager of the coronary business at Medtronic. "With
approval to begin studying this device in the United States, we
hope to demonstrate how this technological advancement enables the
Resolute Onyx DES to become a workhorse device for U.S. physicians
that can increase procedural efficiency and enhance deliverability
in a broad range of vessel sizes.
Resolute Onyx DES also features a new delivery
system with PowerTrac(TM) technology
that was introduced last year with the NC Euphora(TM)
Noncompliant Balloon Dilatation Catheter.
The Resolute Onyx DES received CE (Conformité Européene) mark in November 2014 and is
available for use in countries that recognize the CE Mark. The
Resolute Onyx DES is not available for use in the United States
outside of this clinical program.
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, is the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
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:
Joey Lomicky
Public Relations
+1-763-526-2494
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
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