Medtronic's Solitaire(TM) Stent Retriever Device Receives Expanded Indication from the U.S. Food and Drug Administration for ...
November 16 2016 - 07:01AM
FDA Allows Use of
the Most Studied Stent Retriever with IV-tPA
DUBLIN - Nov. 16, 2016 -
Medtronic plc (NYSE: MDT) today announced that the U.S. Food and
Drug Administration (FDA) has cleared an expanded indication for
the Solitaire(TM) stent retriever device. The FDA now allows the
marketing of the Solitaire device as an initial therapy for acute
ischemic strokes (AIS) for patients with a persistent, proximal
anterior circulation, large vessel occlusion, and smaller core
infarcts to reduce paralysis, speech difficulties and other
stroke-related disabilities. The device should be used after
patients have received intravenous tissue plasminogen activator (IV
t-PA) and within six hours of symptom onset.
"This expanded indication for the Solitaire device
demonstrates Medtronic's ongoing dedication to significantly
improving the lives of stroke patients," said Stacey Pugh, vice
president and general manager of the Neurovascular business, which
is part of the Restorative Therapies Group at Medtronic. "As the
only company with a device studied in all five of the global
clinical trials responsible for changing the stroke treatment in
the American Stroke Association guidelines1 (Early
Management of Patients With Acute Ischemic Stroke Regarding
Endovascular Treatment), we have seen
firsthand how stroke patients benefit from this treatment
option."
The FDA granted the expanded indication based upon
a subset of data from the SOLITAIRE(TM) FR With the Intention For
Thrombectomy as PRIMary Endovascular Treatment for Acute Ischemic
Stroke trial (SWIFT PRIME)2. The data
demonstrates that the addition of the Solitaire device to IV-tPA
significantly decreased post-stroke disability and increased the
number of patients who were functionally independent with mRS
scores of 0-2 within 90 days after a stroke (62.7% vs. 36.8%).
Earlier this year, the Safety and Efficacy of
Solitaire Stent Thrombectomy - Individual Patient Data
Meta-analysis of Randomized Trials (SEER)3, a
meta-analysis of SWIFT PRIME3, Endovascular
Revascularization With Solitaire Device Versus Best Medical Therapy
in Anterior Circulation Stroke Within 8 Hours (REVASCAT)4, EXtending
the Time for Thrombolysis in Emergency Neurological Deficits -
Intra-Arterial (EXTEND-IA)5 and
Endovascular Treatment for Small Core and Proximal Occlusion
Ischemic Stroke (ESCAPE)6, showed a
strong significance in the numbers needed to treat (2.5) to reduce
disability (i.e., for every 2.5 patients treated with the Solitaire
device plus IV-tPA, 1 patient showed improved functional
outcomes).
"Stroke is the fifth leading cause of death in the
U.S. and the number one cause of severe disability," said Jeffrey
L. Saver, MD, FAHA, FAAN, FANA, professor of Neurology, Geffen
School of Medicine at the University of California, Los Angeles and
director, UCLA Comprehensive Stroke Center. "The availability and
access to a technology that reduces stroke disability is critically
important because with such innovations, stroke patients and their
families may experience less physical, emotional and financial
burdens from their condition."
The Solitaire stent retriever device uses a
micro-sized catheter to access arteries in the brain, helping to
restore blood flow and remove large blood clots causing AIS.
Of the 795,000 AIS victims in the U.S., about
240,000 are eligible for treatment with stent retrievers. Despite
this recommendation, currently only about 22,000 procedures are
performed annually.7
Solitaire(TM)
Revascularization Device
The Solitaire(TM) revascularization device
restores blood flow and retrieves clots from occluded blood vessels
in the brain for patients experiencing acute ischemic stroke (AIS)
due to a large vessel occlusion.
Click the thumbnails above for a larger image.
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-
References:
-
2015 American Heart Association/American Stroke
Association Focused Update of the 2013 Guidelines for the Early
Management of Patients With Acute Ischemic Stroke Regarding
Endovascular Treatment. Available at:
http://stroke.ahajournals.org/content/early/2015/06/26/STR.0000000000000074.
Published June 29, 2015. Accessed November 14, 2016.
-
Saver JL, Goyal M, Bonafe A, et al.
Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone
in stroke. N. Engl. J. Med. Jun 11 2015;372(24):2285-2295.
-
Campbell BC, Hill MD, Rubiera M, et al. Safety
and Efficacy of Solitaire Stent Thrombectomy: Individual Patient
Data Meta-Analysis of Randomized Trials. Stroke; a journal of
cerebral circulation. 2016;47(3):798-806.
-
Jovin TG, Chamorro A, Cobo E, et al.
Thrombectomy within 8 hours after symptom onset in ischemic stroke.
N. Engl. J. Med. Jun 11 2015;372(24):2296-2306.
-
Campbell BC, Mitchell PJ, Kleinig TJ, et al.
Endovascular therapy for ischemic stroke with perfusion-imaging
selection. N. Engl. J. Med. Mar 12 2015;372(11):1009-1018.
-
Goyal M, Demchuk AM, Menon BK, et al. Randomized
assessment of rapid endovascular treatment of ischemic stroke. N.
Engl. J. Med. Mar 12 2015;372(11):1019-1030.
-
Statistics from the American Heart
Association/American Stroke Association, World Health Organization
and Centers for Disease Control and Prevention. © 2013
1/13DS6139
Contacts:
David T. Young
Public Relations
+1-508-452-1644
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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