Covidien has announced two-year clinical study results of its Solitaire FR revascularization device, designed for treating acute ischemic stroke.
The FDA-approved and CE-marked mechanical thrombectomy device uses overlapping stent technology to remove blood clot from blocked vessels of internal carotid artery, M1 and M2 segments of the middle cerebral artery, and basilar and vertebral arteries and restore normal blood flow.
The prospective, multi-center, single arm study, SolitaireFR Thrombectomy for Acute Revascularisation (STAR), had enrolled 202 patients and treated them with Solitaire FR device to reopen, or recanalize, the blocked blood vessels.
As determined by an independent Core Lab, the study demonstrated that 84.2% (160/190) of patients with complete angiographic data sets and 79.2% (160/202) of patients with missing angiographic data achieved the highest degree of recanalization (TICI 2b/3).
Long-term follow-up was obtained at 90 days to evaluate neurological health, according to the company.
Functional independence, with little to no disability, was also observed in 57.9% patients with a score of 2 or less, as evaluated by the Modified Rankin Score (mRS).
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.
University Hospital of Geneva interventional neuroradiology head and study principal investigator Vitor Mendes Pereira said, "The results of the STAR prospective, multi-center clinical study demonstrate that mechanical thrombectomy is both safe and effective for the treatment of acute ischemic stroke when treating the right patients, in comprehensive stroke centers, with the Solitaire FR device."