|[February 07, 2013]
Two-Year Clinical Study Supports Safety and Efficacy of Covidien Solitaire™ FR Revascularization Device
MANSFIELD, Mass. --(Business Wire)--
(NYSE:COV), a leading global provider of healthcare products, today
released the results of the Solitaire™ FR Thrombectomy for Acute
Revascularization (STAR (News - Alert)) study. The two-year study evaluated the safety
and efficacy of the Solitaire
FR revascularization device in the treatment of acute ischemic
Covidien's Solitaire FR device is designed to restore blood flow in patients experiencing ischemic stroke. (Photo: Business Wire)
Acute ischemic stroke (AIS) is the most prevalent form of stroke,
representing up to 87% of all stroke-related cases worldwide.1
In AIS, the patient suffers from an acute blockage of blood flow
(ischemia) to the brain, which, if not treated in a timely manner, leads
to permanent neurological damage and possibly death. In 2008, the direct
and indirect cost of stroke in U.S. was $39 billion.2
Covidien's Solitaire FR device is designed to restore blood flow in
patients experiencing ischemic stroke. The device, based on advanced
overlapping stent technology, is used to mechanically remove blood clots
from blocked vessels.
"The findings of the STAR study reflect the recent advances in stroke
treatment," said Jan Gralla, MD, MSc, STAR Principal Investigator,
Department of Diagnostic and Interventional Neuroradiology, Inselspital,
University of Berne, Switzerland. "In highly specialized stroke centers,
endovascular treatment using novel stent retriever technology results in
high rates of good functional outcome and low morbidity."
STAR Study Design and Findings
The prospective, multi-center, single arm clinical study started with an
enrollment of 202 patients at 14 centers across Europe, Australia and
Canada in May 2010, with the last patient completing participation in
October 2012. In the sudy, patients diagnosed with AIS (as confirmed by
radiographic assessment) were treated with the Solitaire FR device in
order to reopen, or recanalize, the blocked blood vessels. The results
of the STAR study indicated that 84.2% (160/190) of patients with
complete angiographic data sets and 79.2% (160/202) of patients with
missing angiographic data, as determined by an independent Core Lab,
achieved the highest degree of recanalization (TICI 2b/3). Long-term
follow-up was obtained at 90 days to evaluate neurological health. Using
the Modified Rankin Score (mRS), 57.9% achieved a score of 2 or less,
indicating functional independence, with little to no disability. In
addition, an independent Clinical Events Committee reported a 6.9%
(14/202) mortality rate and a 1.5% (3/202) symptomatic intracranial
"In the wake of the failed IMS III Study, a NINDS-funded randomized
controlled trial, there will be some physicians who will question the
benefit of mechanical thrombectomy," said Vitor Mendes Pereira, M.D.,
MSc, STAR Principal Investigator, Head of Interventional Neuroradiology,
University Hospital of Geneva, Switzerland. "The results of the STAR
prospective, multi-center clinical study demonstrate that mechanical
thrombectomy is both safe and effective for the treatment of acute
ischemic stroke when treating the right patients, in comprehensive
stroke centers, with the Solitaire FR device."
The results of the STAR clinical study indicate that treatment with the
Solitaire FR device in intracranial anterior circulation occlusions is
Low risk of clinically relevant procedural and device-related
High rates of revascularization (TICI =2b) and Good Clinical Outcomes
(mRS 0-2); and
Low mortality at 90 days.
The data also support the further investigation of the Solitaire FR
device in a Randomized Controlled Trial against best medical treatment.
"We are pleased to report that the STAR study adds to the growing body
of evidence supporting the use of the Solitaire FR device as a superior
tool for revascularization in acute ischemic stroke care," said Mark A.
Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. "Given
the medical and economic burden of AIS to patients and healthcare
systems, there is an urgent need to develop innovative solutions for the
timely, safe and effective treatment of acute ischemic stroke. The
Solitaire FR device represents new hope in addressing this widespread
public health issue."
About AIS and the Solitaire FR Revascularization Device
In the U.S., AIS afflicts approximately 800,000 patients annually and
this number is expected to increase by 22% in the next 20 years.2
It is estimated that, on average, 1.9 million neurons are lost every
minute an AIS goes untreated.3 AIS leads to regions of brain
tissue that have no blood supply and are at risk for permanent tissue
Strokes in general are the leading cause of adult disability in the
Western world and are the second leading cause of death worldwide.4
The Solitaire FR revascularization device is intended to restore blood
flow by removing blood clots from a large intracranial vessel in
patients experiencing ischemic stroke within eight hours of symptom
onset. It is designed for mechanical blood clot removal in the
neurovasculature, including the internal carotid artery, M1 and M2
segments of the middle cerebral artery, Basilar and vertebral arteries.
The Solitaire FR received CE Mark approval in 2009 and U.S. Food and
Drug Administration 510(k) clearance in 2012.
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien manufactures,
distributes and services a diverse range of industry-leading product
lines in three segments: Medical Devices, Pharmaceuticals and Medical
Supplies. With 2012 revenue of $11.9 billion, Covidien has 43,000
employees worldwide in 70 countries, and its products are sold in over
140 countries. Please visit www.covidien.com
to learn more about our business.
1. Wechsler, L.R., Intravenous Thrombolytic Therapy for Acute Ischemic
Stroke. New England Journal of Medicine, 2011. 364(22): p.
2. Writing Group Members, et al., Heart Disease and Stroke
Statistics-2013 Update. Circulation, 2012. 127(1): p.
3. Saver, J.L., Time Is Brain-Quantified. Stroke, 2006. 37(1): p.
4. Donnan, G.A., et al., Stroke. The Lancet, 2008. 371(9624):
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