New Solitaire(TM) Stent Retriever Study Validates Outcomes and Real-World Application of Stroke Treatment Best Practices
February 23 2017 - 2:31PM
Economic Study
Finds Solitaire Stent Retriever Highly Cost-Effective
DUBLIN and HOUSTON - Feb. 23,
2017 - Data presented today on Medtronic's (NYSE:MDT) Solitaire
stent retriever at the International Stroke Conference (ISC) in
Houston demonstrate that the results from the four pivotal
randomized controlled trials - SOLITAIRE(TM) FR With the Intention
For Thrombectomy as PRIMary Endovascular Treatment for Acute
Ischemic Stroke (SWIFT PRIME), Endovascular Treatment for Small
Core and Proximal Occlusion Ischemic Stroke (ESCAPE), EXtending the
Time for Thrombolysis in Emergency Neurological Deficits -
Intra-Arterial (EXTEND IA) and Endovascular Revascularization With
Solitaire Device Versus Best Medical Therapy in Anterior
Circulation Stroke Within 8 Hours (REVASCAT) - can be replicated in
U.S. centers, in a pragmatic, real-world setting reconfirming the
benefits of mechanical thrombectomy in patients suffering acute
ischemic stroke (AIS). Study investigators presented the results
from Systematic Evaluation of Patients
TReated with Neurothrombectomy Devices for
AcuTe Ischemic Stroke (STRATIS)
Registry.
STRATIS is the largest AIS study to date with a
focus on the impact of systems of care on clinical outcomes.
STRATIS examined the impact of treatment delays on patient outcomes
when treated with the Solitaire stent retriever and intravenous
tissue plasminogen activator (IV-tPA), if eligible. In the study,
984 patients were enrolled at 55 centers throughout the U.S.; 64
percent were treated with the Solitaire stent retriever and IV-tPA
and 36 percent were treated with the Solitaire stent retriever
alone. The study found that interhospital transfer was associated
with significant delays to treatment and significantly lower chance
of functional independence at 90 days (60.0 percent vs. 52.2
percent, p=0.02). Further, those treated via balloon guide catheter
(BGC) had higher rates of functional independence at 90 days (61.8
percent vs. 50.2 percent, p=0.002) with fewer passes (1.7 vs. 2.0,
p=0.0008) than patients treated via distal access catheter.
"The STRATIS registry confirms that the outcomes
from four of the global randomized clinical trials that helped to
transform stroke treatment are applicable in different health
systems across the U.S. with the same positive results," said
Curtis Given, M.D., co-director, Neurointerventional Services,
Baptist Health, Lexington, Ky. "We are consistently seeing that
access to stent retrievers reduces long-term disability in
patients. We must continue to work towards a system that makes
early treatment with this technology available to all
patients."
In addition to confirming real-world application, a recent study
published in Stroke, Cost-Effectiveness of
Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke:
Results from the SWIFT-PRIME Trial, found that treatment with both
the Solitaire stent retriever and IV-tPA is highly cost-effective
and an economically dominant strategy with substantial long-term
cost savings and gains in both life-expectancy and quality-adjusted
life-expectancy compared to IV-tPA alone. While initial costs were
higher for the Solitaire stent retriever and IV-tPA compared to
IV-tPA alone ($45,761 vs. $28,578, p<0.001), costs between
patient discharge and 90 days, were $4,904 per patient lower
($11,270 vs. $16,174, p=0.014) for patients treated with the
Solitaire stent retriever than patients treated with IV-tPA alone
due to significant reductions in rehospitalization,
rehabilitation-related, and long-term nursing home costs. Finally,
treatment with the Solitaire stent retriever was associated with
cost savings of $23,203 per patient over a lifetime.
"The cost-effectiveness data shows that despite
higher initial treatment costs, in the long run, patients who
receive stent retriever therapy with the Solitaire stent retriever
spend less time in the hospital, less time in rehabilitation, and
less time in nursing home care after an acute ischemic stroke.
Patients have faster and complete recoveries, and the healthcare
system saves money overall," said Jeffrey L. Saver, M.D., FAHA,
FAAN, FANA, professor of Neurology, Geffen School of Medicine at
the University of California, Los Angeles and director, UCLA
Comprehensive Stroke Center.
The Solitaire stent retriever uses a micro-sized
catheter to access arteries in the brain, helping to restore blood
flow and remove large blood clots causing AIS.
"Medtronic continues to provide ground-breaking
data that shows the impact and now, long-term cost savings of our
Solitaire stent retriever, the most studied of this class of
devices," said Stacey Pugh, vice president and general manager of
Medtronic's Neurovascular business, which is part of the
Restorative Therapies Group. "As the pioneer of stent retriever
technology, we are committed to working with hospitals, providers
and organizations such as the American Heart Association/American
Stroke Association (AHA/ASA) to continue to bring the most
effective stroke treatments to the patients who need it most."
According to the American Heart
Association/American Stroke Association (AHA/ASA), stroke is the
fifth leading cause of death in the U.S. and a leading cause of
disability. In June 2015, the AHA/ASA published new stroke
treatment guidelines that recommended the use of stent retriever
technology - such as the Solitaire stent retriever device - in
conjunction with IV rtPA/alteplase as a first-line treatment for
eligible patients.
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 88,000 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:
Sara Thatcher
Public Relations
+1-901-338-9212
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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