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Published on March 17, 2010

Abington Hospital Surgeon is First in Pennsylvania to Implant Investigative Device to Treat Leg Pain Caused by Spinal Stenosis

New treatment for chronic leg pain now in clinical trials

ABINGTON, PA (March 17, 2010) — Guy Lee, M.D., spine surgeon at Abington Memorial Hospital, was the first in Pennsylvania to treat leg pain and numbness caused by lumbar spinal stenosis using the SuperionTM Interspinous Spacer (ISS) from VertiFlex® Inc.

The procedure performed by Lee is part of a clinical trial to evaluate the safety and effectiveness of this new device in the treatment of leg pain caused by moderate lumbar spinal stenosis. Spinal stenosis, the degenerative narrowing of the spaces in the spine that can lead to spinal cord and/or nerve root compression, is believed to be the cause of leg and back pain for nearly 1.2 million Americans.

The device being tested is a potential alternative to traditional spinal surgery that could act as a support column to open the passageways through which the nerve roots travel from the lumbar spine to the legs. Made of titanium and smaller than a quarter, the Superion ISS is designed to relieve leg, buttock and groin pain resulting from pressure that can be placed on the spinal nerve roots from walking or standing for long periods. It is hoped that patients who are implanted with the Superion ISS may experience a reduction in pain and the possibility of resuming normal daily activities more rapidly after surgery.

"With Superion ISS, I am able to offer patients suffering from moderate spinal stenosis an option that has the potential to relieve their chronic leg pain while preserving their natural anatomy," said Lee, the study's principal investigator at Abington. "With the small incision and straightforward surgical technique for implanting the device, we anticipate the study will show patients can be back on their feet shortly after surgery."

Chronic lower back pain with the radiating leg pain is typically treated conservatively with physical therapy and other non-invasive therapies. If and when such treatments no longer provide relief, patients may be offered a surgical option called spinal decompression which involves the removal of the bone and soft tissue pressing on nerve roots. This procedure can involve a large incision, may result in a relatively lengthy recovery period and may be performed concurrently with a spinal fusion procedure. The intent of Superion ISS is to provide some patients with an alternative to spinal decompression with or without spinal fusion. The new procedure is a minimally invasive surgical technique performed through a single, half-inch skin incision that is designed to stabilize the affected level(s) while allowing the patient to move without significant restriction.

In this study, the Superion ISS is being compared to the X-STOP® Interspinous Process Distraction (IPD® Device, an FDA-approved interspinous spacer that is implanted in a slightly different manner than Superion ISS). Study participants must have been diagnosed with lumbar spinal stenosis and have been undergoing non-operative treatment of unrelieved symptoms for at least six months. They must be over 45 years old, have leg, buttock or groin pain that is relieved by sitting or bending forward, and cannot have a history of prior surgery of the lumbar (lower) spine. The study will determine if this device should be made commercially available in the U.S. To date, the Superion device has been implanted in more than 950 patients worldwide.

Back pain sufferers interested in participating in this trial should call 215-830-0700, extension 3121. For patient education regarding the Superion study, please visit www.superionstudy.com.

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