Medtronic Adds New Resolute Onyx(TM) Drug-Eluting Stent Sizes and Expands Indications
February 01 2016 - 10:00AM
New Extra-Large
Vessel Stent Sizes and Indications in the EU Expand Treatment
Options for Patients with Coronary Artery Disease
DUBLIN - February 1, 2016 -
Medtronic plc (NYSE: MDT) today announced the recent CE (Conformité
Européene) Mark and commercial launch for an expanded size matrix
of the Resolute Onyx DES, a next generation drug-eluting stent that
is now available in 4.5mm and 5.0mm diameter sizes. The CE Mark
also approved several new product indications including treatment
of left main vessels and small vessels. Many coronary vessels are
large in diameter of which a sub-set are left main, and now
physicians can treat these large vessels with optimally sized
stents that provide appropriate drug concentration. Resolute Onyx
is the first DES available in these sizes among major
manufacturers, offering the broadest size matrix to optimize the
treatment of complex clinical scenarios. The Resolute Onyx DES is
not commercially available in the United States.
Treatment of the left main coronary artery is
critical as the artery supplies the majority of blood to the left
side of the heart; a narrowing in this vessel can place the patient
at high risk for life-threatening events. Due to the lack of
optimally sized drug-eluting stents available to date to treat
large coronary arteries, these patients historically have been
treated with undersized stents or with coronary artery bypass graft
surgery (CABG). CABG can be more invasive and may require a longer
recovery period than treatment with drug-eluting stents, while
under-sized stents may have compromised stent scaffold integrity
and disrupted polymer coating when over-expanded.
Resolute Onyx DES is well suited to treat large
coronary vessels including the left main coronary artery with its
optimal sizes and conformability in bifurcation lesions due to
Continuous Sinusoid Technology.
"My initial clinical experience with the large
sizes of the Resolute Onyx DES has been exceptional, as they
alleviate many of the procedural challenges that existed when
smaller stents were often the only option for large vessels," said
David Hildick-Smith, M.D., principal investigator of the EBC Main
Study who performed the first patient case with the larger sized
Resolute Onyx from the Brighton and Sussex University Hospitals NHS
Trust in Brighton, United Kingdom. "In addition, the left main
indication of Resolute Onyx, coupled with its advanced stent
design, provides physicians with a novel device that maintains its
scaffold integrity with increased radial force, which is especially
beneficial when treating bifurcation lesions in large vessels."
Built on the proven clinical performance and
superior deliverability of the Resolute Integrity DES, the expanded
sizes feature the same CoreWire Technology that allows the stent to
have a denser core metal wrapped in a cobalt alloy outer layer.
This technology enables increased radiopacity (i.e., visibility
during the procedure) and has thinner struts to help improve
deliverability without compromising radial and longitudinal
strength. The full size matrix of Resolute Onyx features a delivery
system with PowerTrac(TM) technology
that provides enhanced deliverability through challenging
lesions.
"The expanded size matrix of Resolute Onyx, and
the new indication to treat the left main vessel, further delivers
on our promise to provide the interventional community with stent
innovations that address unmet clinical needs seen in everyday
clinical practice," said Jason Weidman, vice president and general
manager of the coronary and renal denervation business unit at
Medtronic. "We now have a stent that treats a broader range of
patient anatomies - from large to small - than any other major DES
on the EU market."
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 85,000 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:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
HUG#1982465
Medtronic (NYSE:MDT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Sep 2023 to Sep 2024