VERTIFLEX’S SUPERION INTERSPINOUS SPACER APPROVED (Orthopedics This Week)
The FDA issued a rare PMA Approval Order (pre-market approval) on May 26, 2015 as the agency approved VertiFlex, Inc.'s Superion Interspinous Spacer System. The FDA's expert orthopedic panel recommended approval of the device back in February.
Least Invasive Spinal Stenosis Treatment
A statement from the company said the Superion has proven to be a "safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population.” The device is indicated for moderate lumbar spinal stenosis.
The device is designed to achieve indirect spinal decompression for patients suffering from neurogenic intermittent claudication due to moderate lumbar spinal stenosis. It is implanted minimally invasively through a cannula designed to be less traumatic to the patient. It can be implanted under general or local anesthesia.
Indication for Use
The proposed “Indication for Use” for the device, as stated in the PMA, is as follows:
Treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of mo...
