Medtronic Drug-Filled Stent Shows Promising Initial Results Following First Implants
October 12 2015 - 9:00AM
Presented for the
First Time at TCT, Early Results from the RevElution Trial
Demonstrate Early Vessel Healing and Controlled, Polymer-Free Drug
Elution in Patients Treated with the Novel Next-Generation
Stent
DUBLIN and SAN FRANCISCO - Oct.
12, 2015 - Medtronic plc (NYSE: MDT) unveiled today new
data from the first implants of its novel Drug-Filled Stent (DFS)
at the Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium. The early results from an initial subset of patients in
the RevElution Trial show that the DFS achieved rapid and
well-controlled stent coverage. The unique DFS is designed to
eliminate potential drawbacks experienced with bioabsorbable
polymers and polymer-free technologies, such as inflammation due to
polymer degradation, and uncontrolled drug release in the absence
of a polymer.
"The novel DFS truly represents an innovative
stent platform with advanced stent manufacturing to optimize
clinical performance without the need of a polymer," said Stephen
Worthley, professor at the Royal Adelaide Hospital in Adelaide,
Australia and co-principal investigator of the DFS trial who
performed the first implants in the study and presented the data at
TCT. "These patients implanted with the DFS have shown very
promising early outcomes of strut coverage and healing that
indicate the new platform may provide many clinical benefits,
including shorter DAPT duration, and we look forward to evaluating
how well the stent continues to perform throughout the trial."
The Optical Coherence Tomography (OCT) data from
the Trial demonstrate an early healing profile with an average of
90 percent strut coverage (new cell growth over stent struts) at
one month, with a low rate of malapposed struts (2 percent) across
the six patients analyzed. The rate of malapposed struts dropped by
50 percent within one month post-procedure, further demonstrating
the stent's ability to allow for rapid healing within the vessel.
Importantly, the data also showed minimal neointimal hyperplasia
(NIH) formation.
The DFS is built on the proven platform of the
Resolute Integrity(TM) DES with Continuous Sinusoid Technology (a
unique Medtronic method of stent manufacturing that forms one
single strand of wire into a sinusoidal wave enabling a continuous
range of motion), as well as the next-generation Resolute Onyx(TM)
DES with CoreWire Technology that allows it to have a denser core
metal surrounded by a cobalt alloy outer layer for thinner struts
with enhanced radiopacity (visibility during imaging).
The new DFS features a novel tri-layer wire
design, which allows the inner sacrificial layer to become a lumen
continuously coated with drug. The drug (sirolimus) is contained on
the inside of the stent and is released from a single continuous
inner lumen through multiple laser-drilled holes on the abluminal
side (outer surface) of the stent. This allows for a controlled and
sustained polymer-free drug elution over a desired period of time
directly into the arterial wall thereby potentially avoiding
chronic inflammation and adverse vascular responses. In patients
with complex lesions, containing the drug on the inside of the
stent protects the coating to reduce concerns related to coating
durability during tracking.
"Through our collaboration with interventional
cardiologists from around the world to advance our coronary
portfolio together, we believe the drug-filled stent represents a
significant breakthrough in stent design and engineering that helps
address current and next-generation technology challenges," 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.
The global DFS study is underway at multiple sites
in geographies including Australia and Brazil. The study will
enroll 100 patients and will evaluate late lumen loss as measured
by quantitative coronary angiography. The Drug-Filled Stent is
available for investigational use only outside of 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,
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 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 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
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