Thursday, June 26, 2008

The Spine Institute of Louisiana is Selected to Implant an Investigational Device for Patients With Lumbar Spinal Stenosis

BUSINESS WIRE--Most patients facing surgery to correct a painful spinal condition are usually a bit apprehensive. Not so for 70-year-old Marveen Boone of Chase, Louisiana, who will become the first patient in the United States to surgically receive a new investigational device. The VertiFlex® Superion Interspinous Spacer is a small spacing device for lumbar spinal stenosis (LSS). LSS is a common and debilitating problem for people over age 50.

Boones surgery will be performed at the Spine Institute of Louisiana in Shreveport on Thursday, June 26, 2008. Spine surgeon, Pierce D. Nunley, M.D., will be the first surgeon in the United States to implant the new device in a research study. Dr. Nunley states: The instrumentation developed by VertiFlex® allows patients only a small scar and a quicker recovery. It integrates a minimally invasive technique that seeks to preserve all the normal anatomical structures of the spine. This is a good option for patients that would potentially be candidates for traditional fusion a more invasive procedure.

The Superion device is intended to correct LSS by opening the space in the spinal column that has gradually narrowed over time; resulting in pain and numbness from pressure on the spinal cord and nerve roots. The Superion device is implanted through a minimal incision that does not require general anesthesia. The out-patient procedure can be completed in as short as 20 minutes per level.

Compared with traditional fusion procedures, in which patients typically undergo hours of surgery, with extended hospital stays and lengthy rehabilitations, this device hopes to offer patients a much less invasive option, briefer hospital stay and a rapid recovery time. Boone says she cant believe her luck in being the first patient in the U.S. to receive this revolutionary new device here in Shreveport. I am so thankful to have this done without a big procedure. This one is so simple.

The Superion Interspinous Spacer is a titanium metal implant that is delivered through a small 12-15 millimeter incision in the patients back. A small delivery tube is placed through the incision and the device is then opened underneath the patients skin. As the implant is opened the wings embrace the spinous processes of the lower and upper level vertebra of the affected level. Once the device has been opened the delivery tube is removed and the incision is closed.

Superion is available only through this clinical trial at selected sites in the U.S., including the Spine Institute of Louisiana, says Medical Research Director Ajay Jawahar, M.D. He adds, This implant procedure may be a solution for elderly patients who are suffering with LSS, and have been reluctant to have surgery to correct it.

Earl Fender, President and Chief Executive Officer for VertiFlex®, stated: This is a significant milestone for VertiFlex®. The Superion Interspinous Spacer may be a contribution to treating an aging population suffering from spinal stenosis. VertiFlex® looks forward to demonstrating clinical success in the trial so that Superion can soon be offered to the general public.

Superion has already had considerable success in Europe. To date hundreds of Superion devices have been implanted in eight countries by over 30 surgeons.

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