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DePuy Release: FDA Approves First Artificial Disc For Treatment Of Low Back Pain


10/19/2005 5:11:57 PM

RAYNHAM, Mass., Oct. 26 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved the CHARITE(TM) Artificial Disc, a device that treats severe low back pain by replacing a damaged or worn out spinal disc with an artificial one. The approval was announced today by DePuy Spine, Inc., a Johnson & Johnson company, the manufacturer of the disc.

While artificial replacements are commonly used in hips and knees, this is the first FDA approval of such a device for spinal discs.

"The CHARITE Artificial Disc has the potential to revolutionize spine surgery," said Scott Blumenthal, M.D., principal investigator in the CHARITE Artificial Disc clinical trial and an orthopaedic spine surgeon from the Texas Back Institute in Plano. "Until now, spine surgery relieved pain by limiting motion. Now, for the first time, we can relieve pain and preserve motion."

The CHARITE Artificial Disc is a high-tech device made of two metallic endplates and a movable high-density plastic center that, once implanted, is designed to help align the spine and preserve its ability to move. Spinal discs maintain the position of the spine and allow for the flexibility to bend and twist.

Lumbar spinal fusion surgery, a common surgical treatment for low back pain or degenerative disc disease, is often effective in reducing pain, but limits range of motion and may transfer extra stress to discs above and below the fusion site. More than 200,000 of these procedures are performed each year in the U.S.

In clinical trials comparing artificial disc replacement to spinal fusion surgery, CHARITE Artificial Disc patients maintained flexibility, experienced improvements in pain and function, left the hospital sooner and were more satisfied with the procedure. Complication rates for both groups of patients were similar.

CHARITE Artificial Disc Patients Return to Work Sooner

According to John Regan, M.D., a spine surgeon at Cedars Sinai in Los Angeles and a clinical investigator, CHARITE Artificial Disc patients were able to return to work and normal activity sooner than his spinal fusion patients.

"At our center, CHARITE Artificial Disc patients returned to work in 12 weeks or less, which was far better than the spinal fusion patients who were not able to go back to work for about six months," said Dr. Regan.

How the CHARITE Artificial Disc Procedure is Performed

Typically, two surgeons work together in performing the operation. A general or vascular surgeon approaches the spine through an incision in the abdomen and carefully moves internal organs and blood vessels out of the way to provide access to the spine. A spine surgeon then uses special tools to remove the damaged disc and creates a space between two vertebrae for the implantation of the artificial disc. The procedure generally takes one to two hours.

In spinal fusion surgery a damaged spinal disc is removed and vertebrae are joined together using bone grafts and metal screws and/or cages so that motion can no longer occur in this area of the spine. Patients usually have to wear a brace for about three months after surgery.

Not for Everyone, Talk to Your Doctor

Artificial disc replacement is not for everyone. As with any major surgery, there are possible complications that can occur including unresolved pain, allergic reactions, bladder problems and/or infection. Patients should ask their doctors to see if artificial disc replacement is appropriate for them.

More information about the CHARITE Artificial Disc is available at http://www.charitedisc.com/ or by calling 1-866-DISC523. These resources also provide information that will help consumers find a doctor in their area who has been trained in artificial disc replacement.

Currently, there are 15 spine centers throughout the U.S. who offer disc replacement with the CHARITE Artificial Disc. Many more centers are expected within the next several months as surgeons receive extensive training in the procedure. Patients may have to wait several weeks or months while surgeons complete this mandatory training.

Surgeon Training is Top Priority

DePuy Spine is sponsoring a comprehensive training and education program for surgeons. The program is a combination of hands-on surgery, consultation and visitation with top spine surgeons, lectures and web-based educational materials. Much of the training will take place at The Center for Spine Arthroplasty at the Endo-Surgery Institute. More than 50 regional training centers throughout the country will also provide training.

"Training is critical to the appropriate and effective use of the CHARITE Artificial Disc and it will be our top priority," said Earl R. Fender, Worldwide President, DePuy Spine. "Many leading spine surgeons are involved in the design and conduct of the training program to ensure surgeons have the required skills for this advanced surgery."

Back Pain One of the Most Common Problems

About 65 million Americans suffer from low back pain every year, according to the American Association of Neurological Surgeons (AANS). Americans spend about $50 billion each year on low back pain, the most common cause of job- related disability and lost work days.

The CHARITE Artificial Disc is also available in more than 30 countries throughout Europe, Asia, North America, Africa and Latin America.

About DePuy Spine

DePuy Spine, a Johnson & Johnson company, has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years. Today, DePuy Spine stands in the forefront of the worldwide spine market, with a substantial sales organization in the U.S. and an expanding worldwide distribution network. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies.

DePuy Spine, Inc.

CONTACT: Press, Sarah Colamarino, +1-732-524-6259, Jeffrey J. Leebaw,+1-732-524-3350, Roger Kissin, +1-212-527-7533, or Investors, Helen E. Short,+1-732-524-6491, Stan Panasewicz, +1-732-524-2524, all for DePuy Spine, Inc.



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