CoAxia has completed a pivotal trial intended to demonstrate the safety and efficacy of its NeuroFlo cathether as a treatment for ischemic stroke. The trial, SENTIS (Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke) was conducted at leading stroke centers in North America, Europe, and Israel. The trial was designed to determine if this unique method for increasing blood flow to the brain (with a catheter partially occluding the aorta) can minimize the damage caused by stroke and improve outcomes in patients up to 14 hours after the onset of their stroke.
The study was a prospective, controlled, randomized, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization was 1:1 and stratified to ensure equivalent patient distribution for stroke severity and duration. The primary efficacy endpoint was 90-day neurological and functional status. Additional endpoints included safety, perfusion enhancement, 24-hour neurological status, and quality of life.
Eligible subjects were men and women 18 and older with symptoms of an ischemic stroke, NIHSS neurological status score between 5-18, and time from symptom onset less than 14 hours.
Patient enrollment began in early 2006 and was completed in 2010. Over 70 sites participated in the trial and over 500 patients were enrolled. The results of the SENTIS study have been published.
In addition to the pivotal SENTIS trial, CoAxia conducted several feasibility studies. These studies have demonstrated the preliminary safety of using the NeuroFlo catheter in stroke patients up to 24 hours after symptom onset and as an adjunct to intravenous thrombolysis therapy. These feasbility studies have been published.
CoAxia is planning additional studies in the area of ischemic stroke using its unique approach to cerebral perfusion augmentation. If you have ideas for additional or complementary evaluations of NeuroFlo technology, please contact us.
In 2005, CoAxia received FDA approval for the NeuroFlo Catheter to treat patients with cerebral vasospasm under a Humanitarian Device Exemption (HDE). The Model 1027 NeuroFlo catheter is approved for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage (SAH), secured by either surgical or endovascular intervention, for patients who have failed maximal medical management.
Data on vasospasm patients treated with the NeuroFlo catheter demonstrate a complication rate consistent with this severely ill population. Additionally, potential benefit was indicated by an acute neurological improvement of 4 points or greater in the NIHSS score in 50% of the patients.
Centers that may be interested in adding this unique treatment to the management of their subarachnoid hemorrhage population should contact us.
In addition to stroke and vasospasm, CoAxia is evaluating the potential of perfusion augmentation technology for other cerebral, cardiac and renal applications.
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