FDA approval for new clot removal device
Published date : 15 August 2012
Article date : 14 August 2012
Stryker Neurovascular's Trevo Pro Retriever has been granted market clearance by the FDA. The device, launched in Europe in 2010, uses the manufacturer's Stentriever technology for optimised clot integration and retrieval in patients experiencing acute ischemic stroke.
Earlier this year, results of the Thrombectomy REvascularisation of large Vessel Occlusions in acute ischemic stroke study were presented at the International Stroke Conference. 60 patients were enrolled by 7 leading European stroke centers. The study assessed the ability of the Trevo system to remove the blood clots that cause strokes and to restore blood flow to the brain.
Revascularisation, measured by an independent lab, showed high rates in 91.7% of patients. 46% achieved a good outcome in 7 days and at 90 days, the good outcomes rate increased to 55%. Furthermore, the patients with good outcomes were functionally independent (modified Rankin score of 2 or less). A low symptomatic intracranial hemorrhage rate of 5% was also reported.
The Trevo Pro Retriever also demonstrated strong clinical results in the TREVO 2 clinical trial presented at the European Stroke conference in May, this year.
Source: Amanda Pedersen, Medical Device Daily Senior Staff Writer, Medical Device Daily, 14 August 2012
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