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.