Daily Rules, Proposed Rules, and Notices of the Federal Government
The CoAxia NeuroFlo Catheter is a 7F multilumen device with two balloons mounted near the distal tip. The proximal end has a multiport manifold that provides access for the guidewire, monitoring of blood pressure, and independent inflation of the individual balloons. The device is placed in the descending aorta. On March 30, 2005, a humanitarian device exemption application for the CoAxia NeuroFlo Catheter was approved for the following indication for use: The CoAxia NeuroFlo Catheter is intended for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management.
Of note, the CoAxia NeuroFlo Catheter is identical in design to the CoAxia FloControl, which is currently cleared for the following general indications for use:
1. The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature (K023914).
2. The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta (K090970).
CoAxia has submitted a de novo application for the NeuroFlo for the following indication: The CoAxia NeuroFlo Catheter is intended for use in diversion of cardiac output via partial occlusion of the descending aorta, including patients with acute ischemic stroke within 14 hours of symptom onset. The CoAxia NeuroFlo Catheter is also intended for use in selectively stopping or controlling blood flow in the peripheral vasculature, which includes the descending aorta.
FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. In particular, the committee will be asked to discuss the safety and effectiveness data from the "Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke" (SENTIS) clinical trial as they relate to the proposed indications for use.
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