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The Solitaire FR Revascularization Device by Covidien plc won approval for investigational use in the thromectomy part of the Interventional Management of Stroke (IMS III) trial, funded by the National Institute of Neurological Disorders and Stroke.
The IMS III Executive Committee approved the device’s inclusion in the trial and in an amendment made to the FDA.
The Irish company, which has its U.S. headquarters in Mansfield, develops the Solitaire FR device, a device made to improve blood clots and restore blood flow.
The IMS III trial is expected compare two ways to restore blood flow after stroke – the first way uses the current method of giving intravenous rTPA alone, as approved by the FDA, and the second uses a combined intravenous and intra-arterial treatment with the Covidien device.
Covidien (NYSE: COV) announced last week that it had named Stacy Enxing Seng, a co-founder and former executive of ev3 Inc., as president of its Vascular Therapies Global Business Unit.
The company notably announced plans in December to spin off its pharmaceuticals business in order to focus entirely on its medical device and supply business. The business, which is expected to become a stand-alone company, supplies branded generic pain killers, including acetaminophen and hydrocodone.
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