Medtronic Announces Randomized Global Resolute Onyx(TM) DES One-Month Dual Antiplatelet Therapy Study to Address Critical Una...
August 14 2017 - 9:30AM
First-of-its-Kind
Randomized Clinical Trial Will Evaluate One-Month DAPT in Patients
Following PCI Procedures with the Newer-Generation Durable Polymer
Resolute Onyx DES
DUBLIN- August 14, 2017 -
Medtronic plc (NYSE: MDT) today announced a global randomized
clinical trial that will evaluate one-month dual antiplatelet
therapy (DAPT) - the combination of aspirin and an anti-clotting
medication - in patients implanted with the Resolute Onyx(TM)
Drug-Eluting Stent (DES) during percutaneous coronary intervention
(PCI). Designed to evaluate clinical DAPT outcomes between two DES
for the first time ever, the RESOLUTE ONYX ONE-MONTH DAPT Study
intends to help inform DAPT guidelines for newer-generation DES
that currently favor bare-metal stents (BMS) for patients with
stable ischemic heart disease who might require a shorter dual
antiplatelet regimen.
Guidelines regarding DAPT therapies vary
geographically and by patient presentation. Decisions about
duration of DAPT are best made on an individual basis and should
integrate clinical judgment, assessment of the benefit/risk ratio,
product labeling, and patient preference. The RESOLUTE ONYX
ONE-MONTH DAPT Study will enroll up to approximately 2,000 patients
at approximately 70 sites worldwide.
The study further demonstrates the significant
clinical investment from Medtronic to provide relevant DAPT
evidence to physicians for both current and previous generation
DES, including the Zotarolimus-eluting Endeavor Sprint Stent in
Uncertain DES Candidates (ZEUS) Study that showed significant
safety benefits with a previous generation DES vs. BMS in patients
who would typically not receive a DES, such as those at a high risk
for bleeding.
"The ZEUS trial and subsequently, the LEADERS-FREE
trial (which evaluated a different DCS vs. BMS), showed that other
DES systems could be a better alternative to BMS in patients with a
high risk of bleeding," said Stephan Windecker, M.D., of Bern
University Hospital in Switzerland, and principal investigator in
the study." The study addresses the critical question whether newer
generation durable-polymer DES, like Resolute Onyx, that have
demonstrated excellent procedural success in addition to sustained
long-term safety and efficacy, could potentially improve results
even further among these patients."
Results from the RESOLUTE ONYX ONE-MONTH DAPT
Study will also build on the RESOLUTE Pooled DAPT Interruption
analysis that showed no increased risk of stent thrombosis with
DAPT interruption or discontinuation after one-month.
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.
"We're continuously looking at ways to invest in
clinical evidence and expand our product portfolio to help address
the most important unanswered questions and unmet needs in
interventional cardiology," said Martin Rothman, M.D., vice
president, medical affairs for the Coronary and Structural Heart
division, which is part of the Cardiac and Vascular Group at
Medtronic. "In addition to generating new, meaningful evidence to
help guide clinical practice, we are also looking to develop
next-generation technologies that will build on the exceptional
deliverability that physicians have come to expect with our stent
platforms. Along with DES, our pipeline includes a cadre of other
tools that will help interventional cardiologists improve patient
outcomes and address unmet clinical needs around the world."
Stents from the Resolute DES family have been
implanted in more than six million patients around the world, one
million of whom have been implanted with the latest generation
Resolute Onyx DES. The Resolute Onyx DES received CE (Conformité Européene) Mark in September 2014 and FDA
approval in April 2017.
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 91,000 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-
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
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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