Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the Solitaire™ FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR revascularization device in the treatment of acute ischemic stroke.
Covidien's Solitaire FR device is designed to restore blood flow in patients experiencing ischemic stroke. (Photo: Business Wire)Acute ischemic stroke (AIS) is the most prevalent form of stroke, representing up to 87% of all stroke-related cases worldwide. 1 In AIS, the patient suffers from an acute blockage of blood flow (ischemia) to the brain, which, if not treated in a timely manner, leads to permanent neurological damage and possibly death. In 2008, the direct and indirect cost of stroke in U.S. was $39 billion. 2 Covidien’s Solitaire FR device is designed to restore blood flow in patients experiencing ischemic stroke. The device, based on advanced overlapping stent technology, is used to mechanically remove blood clots from blocked vessels. “The findings of the STAR study reflect the recent advances in stroke treatment,” said Jan Gralla, MD, MSc, STAR Principal Investigator, Department of Diagnostic and Interventional Neuroradiology, Inselspital, University of Berne, Switzerland. “In highly specialized stroke centers, endovascular treatment using novel stent retriever technology results in high rates of good functional outcome and low morbidity.” STAR Study Design and Findings The prospective, multi-center, single arm clinical study started with an enrollment of 202 patients at 14 centers across Europe, Australia and Canada in May 2010, with the last patient completing participation in October 2012. In the study, patients diagnosed with AIS (as confirmed by radiographic assessment) were treated with the Solitaire FR device in order to reopen, or recanalize, the blocked blood vessels. The results of the STAR study indicated that 84.2% (160/190) of patients with complete angiographic data sets and 79.2% (160/202) of patients with missing angiographic data, as determined by an independent Core Lab, achieved the highest degree of recanalization (TICI 2b/3). Long-term follow-up was obtained at 90 days to evaluate neurological health. Using the Modified Rankin Score (mRS), 57.9% achieved a score of 2 or less, indicating functional independence, with little to no disability. In addition, an independent Clinical Events Committee reported a 6.9% (14/202) mortality rate and a 1.5% (3/202) symptomatic intracranial hemorrhage rate.