Covidien’s CE Marked Revascularisation Device Now Approved for US Trial

“The Solitaire FR is the first stent-based mechanical thrombectomy device allowed into the study by IMS III investigators”


Covidien has announced that the Solitaire™ FR Revascularization Device has been 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 U.S. Food and Drug Administration (FDA). The device already carries CE marking.


According to Covidien, the Solitaire FR device has become the leading technology for the endovascular treatment of acute ischemic stroke outside the United States. The high success rate, fast procedure time and ease of use experienced by physicians in Europe and other regions who have used the device led physicians to request that it be included in the IMS III Trial.

The IMS III trial

The trial will compare a combined intravenous (IV) and intra-arterial (IA) treatment approach to restoring blood flow to the brain to the current standard FDA-approved treatment approach of giving IV rTPA alone. A projected 900 subjects with moderate to severe ischemic stroke will be enrolled at over 50 centers in the United States, Canada, Australia and potentially Europe. The Executive Committee approved the Solitaire FR device to ensure that the study and patients have the most advanced treatment technologies to help determine the role of endovascular therapy in acute ischemic stroke.

Clinician comments

“We are excited to include the Solitaire FR Revascularization Device in the National Institute of Neurological Disorders and Stroke-funded IMS III trial. The addition of the device will help to expedite the completion of this critical trial,” said Dr. Joseph Broderick, IMS III Principal Investigator, Professor and Chair of the Department of Neurology, University of Cincinnati.

Company comments

“The Solitaire FR is the first stent-based mechanical thrombectomy device allowed into the study by IMS III investigators,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “We look forward to the important results that will follow from this study around the optimal treatment of acute ischemic stroke.”

Covidien financial update

The release of this information coincides with Covidien’s release of recent financial data which show a 4.7% year on year revenue increase, with medical device sales actually growing 6%. Gross margin for the period also grew by 1.2% to 58.8% for the quarter. Commenting on the results, Covidien’s Chairman, President and CEO Jose Almeida said;   “We are off to an excellent start in fiscal 2012, with good sales gains, record gross and operating margins and double-digit EPS growth. This strong performance was again led by our largest business segment, medical devices, which delivered growth fueled by double-digit advances in energy and vascular products.”

In a separate statement the company’s CFO Charles Dockendorff referred to the impending 2.3% tax levy, stating that; “We get these kind of increases in raw materials or currency that are far greater than that all the time. So it’s just another business issue, that we will deal with as we look in 2013.”

Source: Covidien