International health care product major,
), has initiated a new study, SWIFT PRIME. The main objective of
this study is to find out the efficacy of the Solitaire FR
Revascularization Device to treat acute ischemic stroke.
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Stroke is the fourth leading cause of death in the U.S.,
according to the American Heart Association. Ischemic stroke
occurs when a blood vessel carrying oxygen and nutrients to the
brain is clogged.
The Solitaire FR device, an overlapping stent-based technology,
mechanically removes blood clots from blocked vessels, restoring
blood flow to the brain in patients ailing from stroke. The
device has won the approval of the U.S. Food and Drug
Administration ("FDA") in March 2012 and is already approved
outside the U.S. for the endovascular treatment of acute ischemic
stroke, offering physicians with an innovative treatment
technology over the existing therapy options.
The new clinical trial has enrolled its first patient at the
Buffalo University and may enroll roughly 800 patients across 60
medical centers worldwide. Deemed to be one of the largest global
medical studies, it will examine the effectiveness of mechanical
thrombectomy using the Solitaire device in stroke care. The trial
will also incorporate a health economic analysis.
The Solitaire FR offering from Covidien's Vascular business under
the core Medical Devices segment is gaining significant market
share, as evidenced by the 4% year-over-year growth experienced
by the Vascular business in the last reported quarter. However,
the company's product offerings under its larger Medical Device
segment are similar to some of its competitors like
Johnson & Johnson
Becton, Dickinson and Company
CR Bard Inc.
Covidien currently carries a Zacks Rank #3 (Hold), which supports
our long-term Neutral recommendation on the stock.