By Sheila Dwyer, MedTech1 Staff
Chronic lower back pain is a frustrating health problem that approximately four out of five adults will suffer during their lifetimes. It is also a mystery to many health professionals. Some people diagnosed with back pain find that the physical therapy and lifestyle modifications suggested by doctors cannot begin to ease their pain.
Surgery, a last resort therapy, is required when less invasive pain relief methods are inadequate. Raymedica, Inc., a United States-based company, has developed a solution for degenerative disk disease (DDD) that has won fans in Europe and other areas of the world while awaiting Food and Drug Administration (FDA) approval in the United States.
DDD is a back problem usually caused by trauma or aging. It is present when intervertebral disks located between the vertebrae lose their height, causing pain in the low back and legs. The disks, which are like shock absorbers for the spine, start out as fluid-filled sacs in children and change into tough and unmalleable disks by late adulthood. When the disks become distorted, they can create pressure on surrounding nerves. If an activity or injury causes the disk’s outer membrane to tear, the disk can injure the spinal cord or the nerves associated with it, causing extreme back pain.
Manuel Ruland of Germany was diagnosed with DDD in October 1997. His pain was located mainly in his lower back and left leg, and his symptoms were numerous: “Pain in the left leg, sleeping problems, no chance to sit for more than 30 minutes, problems driving a car, etc.” A trip to the doctor brought little relief—Manuel was told to try physical therapy and was still unable to control his pain.
After about a year later, Manuel’s doctor recommended Raymedica’s PDN Prosthetic Disc Nucleus device. The PDN device is indicated in Europe for treatment of patients with mild to moderate DDD resulting in low back pain that has not responded to conservative care. It aims to maintain or increase disc height as well as maintain or improve range of motion. Most importantly, it strives to reduce back pain. During PDN implantation, two devices are implanted side by side transversely to minimize the size of the surgical hole.
In May 1998, Manuel underwent his first PDN implant surgery. After three months, the back pain started again, when one of the implants began to affect a nerve. He had a second PDN implant surgery in October 1998, and has been problem-free ever since.
“I was able to walk after six to eight hours, slowly but surely. I was asked to get up to the bathroom on my own. It was painful, but it worked,” Manuel reports by email from Germany. After five days in the hospital, Manuel did physical therapy in a rehabilitation hospital for four weeks, two hours per day.
He says now that he has no limitations. He is a golfer, a volleyball player, and a manager at a large corporation. PDN is “the best thing that ever happened to me (besides my wife and family). I am absolutely pleased and satisfied.”
This is good news to Raymedica, Inc. The company is currently working with the FDA to gain IDE approval for phase two of its clinical investigations in the United States.
For more information on Raymedica, Inc. visit them at www.raymedica.com.
