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International health care products major Covidien’s ( COV - Analyst Report ) Solitaire FR revascularization device has been cleared for investigational use in the Interventional Management of Stroke (“IMS III”) trial.
The Ireland-based company said that the device was approved by the IMS III Executive Committee in the thrombectomy arm of the study and was included in a recently approved amendment submitted to the U.S. Food and Drug Administration (FDA).
The Solitaire FR device is 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 device’s inclusion in the IMS III trial has been triggered by its high success rate, rapid procedure time and ease of use experienced by physicians in Europe and other areas.
The IMS III study has been designed to compare a combined intravenous and intra-arterial treatment approach to restoring blood flow to the brain to the current standard FDA-approved treatment approach of giving intravenous recombinant tissue plasminogen activator (rTPA) therapy alone.
An estimated 900 patients with moderate to severe ischemic stroke will be enrolled in the trial at over 50 centers across the U.S., Canada, Australia and potentially Europe. The Executive Committee cleared Solitaire FR to make sure that the trial and patients have the most advanced technologies to help assess the role of endovascular therapy in acute ischemic stroke.
Covidien is a leading global health care products company with a rich history of developing high-quality products in a cost-effective manner. It competes with Johnson & Johnson ( JNJ - Analyst Report ) , Becton Dickinson ( BDX - Analyst Report ) and C.R. Bard ( BCR - Analyst Report ) , among others.
Revenues from Covidien’s core Medical Devices segment climbed 6% year over year to $1.98 billion in the most recent quarter, powered by double-digit growth across Vascular and Energy Devices product-lines.
The Vascular business had another strong quarter with revenues soaring 17% to $387 million, spurred by double-digit growth of venous insufficiency and neurovascular products. Our long-term Neutral recommendation on Covidien is supported by a short-term Zacks #3 Rank (Hold).
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