Covidien gets FDA go-ahead to trial revascularization device for stroke
Covidien's Solitaire FR revascularization device has been FDA approved for investigational use in the Interventional Management of Stroke (IMS III) trial. The Solitaire FR device was approved by the IMS III executive committee in the thrombectomy arm of the trial and was included in a recently approved amendment submitted to the FDA.
The IMS III trial will compare a combined intravenous and intra-arterial (IA) treatment approach to restoring blood flow to the brain to the current standard FDA-approved treatment approach of giving intravenous rTPA alone.
A projected 900 subjects with moderate to severe ischemic stroke will be enrolled at over 50 centers in the U.S., Canada, Australia and potentially Europe, according to the Dublin-based company. Joseph P. Broderick, MD, chair of the department of neurology at the University of Cincinnati College of Medicine, has been named the principal investigator of the IMS III trial.
In some areas outside the U.S., the Solitaire FR device is approved for the endovascular treatment of acute ischemic strokes.
The IMS III trial will compare a combined intravenous and intra-arterial (IA) treatment approach to restoring blood flow to the brain to the current standard FDA-approved treatment approach of giving intravenous rTPA alone.
A projected 900 subjects with moderate to severe ischemic stroke will be enrolled at over 50 centers in the U.S., Canada, Australia and potentially Europe, according to the Dublin-based company. Joseph P. Broderick, MD, chair of the department of neurology at the University of Cincinnati College of Medicine, has been named the principal investigator of the IMS III trial.
In some areas outside the U.S., the Solitaire FR device is approved for the endovascular treatment of acute ischemic strokes.