Medtronic to Initiate Clinical Study of Drug-Filled Stent Following Successful Preclinical Results
15 March 2015 - 9:45AM
Novel Platform
Enables Controlled, Polymer-Free Drug Elution, Designed to Help
Address Next-Generation Technology Challenges
DUBLIN and SAN DIEGO -
March 14, 2015 - Advancing its interventional
coronary portfolio with breakthrough engineering concepts in device
design and technology, Medtronic plc (NYSE: MDT) unveiled the
preclinical outcomes of its novel Drug-Filled Stent (DFS) at the
64th Annual Scientific Session of the American College of
Cardiology (ACC). The preclinical data showed controlled and
efficacious drug elution into the arterial wall without a polymer
carrier, while reducing diameter stenosis and achieving complete
stent coverage quickly without inflammation. Based on these
results, Medtronic plans to initiate a clinical trial in the coming
months.
The first global DFS study will be conducted at
multiple sites in geographies including Australia and Brazil. The
clinical study will enroll 100 patients and will evaluate late
lumen loss as measured by quantitative coronary angiography. Gregg
W. Stone, M.D., director, cardiovascular research and education,
Center for Interventional Vascular Therapy, Columbia University
Medical Center, New York-Presbyterian Hospital, will serve as the
global chairperson of the Global Clinical Program executive
committee. The study co-principal investigators are Prof. Stephen
Worthley of Royal Adelaide Hospital, Adelaide, Australia and Dr.
Alexandre Abizaid of Instituto Dante Pazzanese de Cardiologia, São
Paolo, Brazil.
"Second-generation DES technologies have shown
better clinical outcomes compared to first generation DES in a
broad spectrum of patient anatomies and subsets, however,
controlled polymer-free drug elution has the potential to further
optimize acute performance, improve near-term and long-term
clinical outcomes and potentially allow for a shorter DAPT
duration," said Dr. Stone.
The innovative DFS is built on the proven platform
of the Resolute Integrity DES with Continuous Sinusoid Technology
(a unique Medtronic method of stent manufacturing that molds one
single strand of wire into a sinusoidal wave enabling a continuous
range of motion), as well as the next-generation Resolute Onyx DES
with CoreWire Technology that allows it to have a denser core metal
surrounded by a cobalt alloy outer layer. The new DFS features a
novel tri-layer wire design, which allows the inner most core layer
to be removed, so that the hollow strut lumen functions as an
internal drug reservoir. Drug is eluted from the core upon
implantation through abluminal side holes on the surface of the
stent, which allows for controlled, polymer-free drug elution over
a desired period of time directly into the arterial wall to
potentially avoid chronic inflammation and adverse vascular
responses.
"While investigating some of the latest
innovations - including both bioabsorbable polymers and
polymer-free technologies - we identified several potential
drawbacks," said Jason Weidman, vice president and general manager
of the Medtronic coronary business. "The internally-loaded DFS has
been developed to control drug release in the absence of a polymer
carrier and eliminate inflammation due to polymer degradation. It's
encouraging to see that the preclinical data confirm the ability of
the DFS to address these issues and we believe the clinical program
will support the position of DFS as a premium product that brings
meaningful advantages to clinicians and patients."
The Drug-Filled Stent is available for
investigational use only and it is not approved for use outside of
clinical studies. The Resolute Onyx DES received CE Mark in
November 2014 and is an investigational device in the United
States.
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:
Wendy Dougherty
Public Relations
+1-763-381-1204
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
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