Success for Solitaire FR (Covidien) in STAR revasculization study

Covidien reports results from the two year Solitaire FR Thrombectomy for Acute Revasculization study(STAR study). 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. In the study, patients diagnosed with Acute Ischaemic Stroke (AIS) (as confirmed by radiographic assessment) were treated with the Solitaire FR revasculization 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.