Healthcare products company Covidien has presented two-year clinical study results of its mechanical thrombectomy device, used for treating acute ischemic stroke.
Using overlapping stent technology, the FDA-approved and CE-marked Solitaire FR revascularisation device removes blood clots from blocked vessels of the internal carotid artery, M1 and M2 segments of the middle cerebral artery and basilar and vertebral arteries to restore normal blood flow.
The prospective, multi-centre, single-arm study, SolitaireFR thrombectomy for acute revascularisation (STAR), enrolled 202 patients and treated them with the device to reopen, or recanalise, 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 recanalisation (TICI 2b/3).
Neurological health was also assessed after 90 days, 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).
An independent Clinical Events Committee also reported a 6.9% (14/202) mortality rate and a 1.5% (3/202) symptomatic intracranial hemorrhage rate.
University of Berne Inselspital diagnostic and interventional neuroradiology department neuroradiologist and study principal investigator Dr Jan Gralla said; “In highly specialised stroke centers, endovascular treatment using novel stent retriever technology results in high rates of good functional outcome and low morbidity.”
University Hospital of Geneva interventional neuroradiology head and study principal investigator Dr 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.”
Image: Solitaire FR Revascularisation device retrieves clot,restores blood flow in patients with acute ischemic stroke. Photo: Courtesy of Covidien.