Global Trials Show Addition of Medtronic’s Solitaire™ Device Stent Thrombectomy Procedure in Treatment of Acute Ischemic ...
April 17 2015 - 7:08AM
Business Wire
SWIFT PRIME and REVASCAT Confirm Findings of
EXTEND-IA, ESCAPE and MR CLEAN, Support Addition of Solitaire Stent
Thrombectomy to Current Standard of Care
Two global trials published online in The New England Journal of
Medicine (NEJM) and presented at the European Stroke Organisation
Conference found that the addition of the Solitaire™ device stent
thrombectomy procedure to current pharmaceutical treatment
significantly reduced disability in patients suffering stroke.
These trials confirmed the findings of three previous trials also
published in NEJM.
Research published online in The New
England Journal of Medicine found that the addition of Medtronic’s
Solitaire™ device stent thrombectomy procedure to current
pharmaceutical treatment significantly reduced disability in
patients suffering stroke. (Photo: Business Wire)
Both the SOLITAIRE™ FR With the Intention For Thrombectomy as
PRIMary Endovascular Treatment for Acute Ischemic Stroke (SWIFT
PRIME) and Endovascular Revascularization With Solitaire Device
Versus Best Medical Therapy in Anterior Circulation Stroke Within 8
Hours (REVASCAT) trials assessed if patients experiencing an acute
ischemic stroke (AIS) and treated with the Solitaire device in
addition to current medical therapy, including IV-tPA when patients
were eligible, had less stroke-related disability than patients
treated with IV-tPA or medical therapy alone. SWIFT PRIME was
sponsored by Medtronic plc (NYSE: MDT) and REVASCAT was supported
by an unrestricted grant from Medtronic.
SWIFT PRIME assessed 196 patients and found that the addition of
the Solitaire device significantly decreased post-stroke disability
and increased the number of patients who were independent within 90
days after a stroke. The trial found that the addition of the
Solitaire device significantly increased patients’ rate of return
to functional independence compared to IV-tPA alone (60.2% vs.
35.5%, p=0.0002).
“SWIFT PRIME showed that treatment with the Solitaire device is
safe, technically successful and substantially reduces long-term
disability levels,” said Jeffrey L. Saver, MD, FAHA, FAAN, FANA,
professor of Neurology, Geffen School of Medicine at the University
of California, Los Angeles (UCLA) and director, UCLA Comprehensive
Stroke Center. “This treatment marks the beginning of a new era in
stroke care.”
Similarly, REVASCAT (206 patients) showed that patients treated
with the Solitaire device in addition to medical therapy (which
included IV-tPA in eligible patients that comprised 70 percent of
subjects enrolled) up to eight hours from onset of symptoms,
experienced a statistically significant improvement in the rate of
return to functional independence (43.7% vs. 28.2%) in favor of
patients treated with the Solitaire device when compared to medical
therapy alone.
Both SWIFT PRIME and REVASCAT confirmed the findings of
EXtending the Time for Thrombolysis in Emergency Neurological
Deficits - Intra-Arterial (EXTEND-IA), Endovascular Treatment for
Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) and
Multi center Randomized Clinical trial of Endovascular treatment
for Acute ischemic stroke in the Netherlands (MR CLEAN), global
trials also published in NEJM. All of these trials have shown that
the amount of time to treatment has a significant impact on
outcomes. SWIFT PRIME demonstrated dramatic improvements in
workflow (the complete cycle of care from diagnosis through
treatment) compared to previous trials. The trial was conducted at
39 centers across seven countries, demonstrating broad
applicability in different health systems and the achievability of
fast, efficient stent thrombectomy care.
REVASCAT was conducted at four comprehensive stroke centers in
Catalonia, Spain covering a population of 7.5 million people. In
looking at the overall population, 85 percent of the population of
protocol-eligible patients were enrolled in the trial. The broad
eligibility criteria and the high enrollment achieved in the
REVASCAT trial, therefore, make the positive results of the
Solitaire device highly generalizable to a sizable majority of
those who suffer strokes in Catalonia.
“We now have five global trials that provide an overwhelming
body of clinical evidence in support of Solitaire stent
thrombectomy,” said Antoni Davalos, MD, director, Department of
Neurosciences, Hospital Universitari Germans Trias i Pujol. “Based
on these findings, it is time for the stroke community to come
together to re-evaluate stroke treatment guidelines and to look for
systems to facilitate the access of treatable patients to
specialized centers.”
The Solitaire device uses a micro-sized catheter to access
arteries in the brain affected by stroke through an incision in the
leg. Once delivered, the Solitaire device helps to immediately
restore blood flow and remove the blood clots causing the
stroke.
“These findings are bringing the global stroke treatment
community together to rethink how we provide stroke care,” said
Brett Wall, president of the Neurovascular business, which is part
of the Restorative Therapies Group at Medtronic. “Improving patient
access to the proven Solitaire device stent thrombectomy procedure
is an important objective for all of us who are committed to
fighting stroke. We support the revision of guidelines and the
benefit that this will drive to patients, health systems and our
broader society.”
According to the World Stroke Organization, stroke is the fifth
leading cause of death worldwide and contributes to nearly 6
million deaths around the globe.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, 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.
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MedtronicDavid T. Young, +1-508-452-1644Public
RelationsorInvestor RelationsJeff Warren, +1-763-505-2696
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