FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: CoAxia NeuroFlo™ Catheter
Manufacturer: CoAxia, Inc.
Address: 10900 73rd Ave. N Suite 102 Maple Grove, MN 55369
Approval Date: March 30, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/H030005a.pdf
What is it?
The NeuroFlo Catheter is a long, flexible tube with two small balloons on one end that is used to partially block blood flow in large blood vessels. The NeuroFlo™ Catheter is used to treat cerebral ischemia, a condition that occurs when the brain does not receive enough blood flow to maintain normal neurologic function such as speech, movement and understanding.
How does it work?
- Placement of the NeuroFlo™ Catheter is guided by fluoroscopy.
- The catheter is placed in the large blood vessel (aorta) that leads from the heart to the lower part of the body through a small hole in the upper part of the leg.
- The balloons on the catheter are inflated for approximately 45 minutes.
- The assumption is that during this time, blood flow to the lower part of the body will be reduced while blood flow to the upper part of the body, including the brain, will be increased.
- When the procedure is completed, the catheter is removed.
When is it used?
The NeuroFlo™ Catheter is used for the treatment of cerebral ischemia resulting from symptomatic vasospasm in patients who have not responded to other forms of treatment. Symptomatic vasospasm is the squeezing down of a blood vessel in the brain that results in symptoms similar to stroke such as difficulty in speaking, movement, or understanding.
What will it accomplish?
The NeuroFlo catheter may improve the symptoms of vasospasm and neurological condition.
When should it not be used?
The Neuroflo™ Catheter should not be used in:
- Patients with significant left ventricular dysfunction
- Patients with aortic aneurysm including those which have been treated with endovascular grafts
- Patients with a history of bleeding disorders
- Patients who are pregnant