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March 7, 2008

FDA-Approved Procedure for Herniated Discs in the Cervical Spine Performed at St. Luke's Hospital - Allentown Campus is a Regional First

Artificial disc procedure allows patients to maintain motion and flexibility in their necks

Jeffrey R. McConnell, MD, a spine surgeon with the Pennsylvania Spine and Scoliosis Institute for OAA Orthopaedic Specialists, is using a new surgical technique that offers patients with herniated discs in the cervical spine an alternative to spinal fusion procedures. Following FDA approval, he became first in the region to perform the procedure with the PRESTIGE® cervical disc at St. Luke's Hospital-Allentown Campus August 30, 2007.

The new technique called cervical disc arthroplasty relieves neck pain and arm pain and enables patients to maintain neck motion, giving them improved function post surgery. Dr. McConnell has successfully performed about 25 of these procedures using PRESTIGE cervical disc, including cases performed during the clinical trials phase over the past two years. Additionally, Dr. McConnell is currently involved in a clinical trial for the SECURE® -C artificial cervical disc and has performed 22 procedures as a part of this trial.

“Age, injury and wear and tear over time can cause damage or herniation of the cervical disc,” says Dr. McConnell. “As a result the disc's shock absorbing qualities decrease, which may result in a disc herniation. Pain, numbness and weakness in the arm may occur as pressure is placed on the surrounding nerves and spinal cord.”

For some patients, non-surgical treatments including physical therapy and anti-inflammatory medications may provide relief for symptoms caused by cervical disc herniation. When these methods fail, surgery is typically recommended. Until now, spinal fusion, which employs metal plates and screws to immobilize the vertebrae and stabilize the cervical spine, was recommended. While the procedure alleviates pain, it also reduces motion and flexibility. In contrast, this new artificial disc relieves pain while maintaining motion.

During this new procedure, a stainless steel device called the PRESTIGE® Cervical Disc from Medtronic is inserted through a small incision at the front of the neck. The diseased disc is removed and replaced with the artificial disc. The device comes in a variety of sizes so a patient's anatomy can be closely matched.

The procedure is performed under general anesthesia. In many cases, patients may be released from the hospital the following day. During the healing process at home, patients wear a soft cervical collar for about seven days. Some patients experience full mobility in a few weeks following surgery.

“What excites me the most about the PRESTIGE Cervical Disc is that my patients who want to maintain motion in their necks have this new option,” said Dr. McConnell. “Many of us who are healthy take simple movements for granted. For people who have suffered with chronic neck and arm pain, having the ability to look up and down and side to side easily and without pain is a tremendous achievement. This disc is giving patients a great option, one that may very well revolutionize treatment for surgical patients who normally would have only the option of a motion-restricting operation of spinal fusion.”

Brian Yackanicz, a patient of Dr. McConnell's from Lehighton, recently underwent cervical disc arthroplasty at St. Luke's Hospital-Allentown Campus. “The surgery went fine and I felt good the same day,” he said. “Most importantly, my pain is now gone. I would highly recommend this surgery to others with my condition.”

This is the first artificial disc approved for the cervical spine by the U.S. Food and Drug Administration. In the U.S. clinical trial of the PRESTIGE Cervical Disc, patients who received the disc showed improved neurological success at 24 months and improved overall success. The clinical trial was the largest, completed, prospective randomized controlled study of its kind in the cervical spine having enrolled a total of 541 patients.

“It is important for people with herniated discs in their neck to discuss their options with their doctor,” says Dr. McConnell. “The first step is determining the extent of the cervical disc problem and whether surgery is a viable option for their treatment.”

Since FDA-approval of the Prestige Cervical Disc, neurosurgeon, Daniel O'Rourke, MD, of Allen Neurosurgical Associates, has been performing procedures with the Prestige Cervical Disc at St. Luke's Hospital-Bethlehem Campus.

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