MINNEAPOLIS, Feb. 12 /PRNewswire/ -- CoAxia™, Inc. of Maple Grove, MN, announced today the completion of enrollment in its SENTIS randomized, controlled, pivotal trial of NeuroFlo™ Perfusion Augmentation Therapy as an acute interventional treatment for ischemic stroke. The Company plans to complete data collection and analysis of results in Q3 of 2010 and, if warranted, submit a PMA to the US FDA.
Ischemic stroke is one of the largest causes of death and disability in the western world, affecting over 650,000 patients annually in the United States alone, and responsible for $70B in annual costs for the long term care of stroke-disabled patients. Whereas in the US approximately 5% of ischemic stroke patients are treated acutely, CoAxia believes that if the NeuroFlo treatment proves safe and effective, as many as 50% of stroke patients may become eligible for treatment – a significant potential benefit to stroke patients and the healthcare system.
The SENTIS trial is being performed in the US and Europe under an FDA IDE, and includes ischemic stroke patients treated within 14 hours of the onset of symptoms. By comparison, the only other approved stroke therapy in the US is the intravenous delivery of the thrombolytic drug tPA, which is approved for a three hour time window. SENTIS is a 1:1 randomized, controlled study with a neurological improvement endpoint measured at 90 days after symptom onset. The outcome measure is the Stroke Global Score as defined by the National Institute of Neurological Disease and Stroke (NINDS). With 515 patients enrolled at over 50 stroke centers in 10 countries, CoAxia believes that it will have sufficient patients and site diversity to accurately measure s
|SOURCE CoAxia, Inc.|
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