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First Artificial Disc
1 April 2006
University of Arizona Health Sciences Center
KOLD News 13 Reporter
Patients with painful degenerative disc disease now have a new treatment option right here in Tucson.
It's a first in southern Arizona. Doctors at University Medical Center have implanted artificial discs in a patient.
"I feel this procedure was worthwhile", said Brian Bosse, a patient who underwent the surgery.
Brian Bosse wasn't always able to sit comfortably in his chair. He developed three lower back disc herniations, and looked all over for options to ease his pain. "I ended up going through therapy and as time went on I didn't get a solution to these problems."
After researching artificial disc replacement surgery online and in magazines, Brian found a doctor who was willing to see him.
A University Medical Center Surgeon, Dr. Robert Dzioba, led the surgical team that performed Brian's surgery. First, a vascular surgeon made an incision through the lower abdomen and moved blood vessels and internal organs aside. Next, Dr. Dzioba, removed the two damaged discs and carefully implanted the artificial discs.
The discs are made of metal and there's a plastic center designed to align the spine and preserve its ability to move.
Before this new procedure was available, those suffering from degenerative disc disease had limited treatment options, including fusing the vertebrae together.
Dr. Dzioba says the perfect patients are those who are middle-aged and have one or two bad discs. Those suffering from osteoporosis, serious arthritis or scoliosis should look for other procedures that could help their disease.
"Ultimately, the really great achievement would be if we could offer this to old people. We could put in some type of device," Dr. Dzioba said.
A device that allows Brian to live pain-free. "Only five days in the hospital and I walked out of there, on my own two feet, " said Brian Bosse.
SpinalMotion Enrolls 80th Patient in U.S. Cervical and Lumbar Artificial Disc Clinical Studies
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Sept. 27, 2005
Worldwide Clinical Experience Tops 600 Patients; Company Secures $5 Million Growth Capital Line
SpinalMotion, developer of investigational artificial discs for treating patients with degenerative disc disease, today reported significant progress on two clinical trials aimed at evaluating its Kineflex(TM) lumbar disc and Kineflex/C(TM) cervical disc implants.
Earlier this year, the company received Investigational Device Exemption (IDE) approvals from the U.S. Food & Drug Administration (FDA) to commence the studies, which began during the second quarter. As of now, over 80 patients are enrolled in the U.S.-based studies, bringing to over 600 the number of patients worldwide implanted with a Kineflex disc. The company is also expected to close a $5 million growth capital line next month.
The SpinalMotion Kineflex lumbar disc and the Kineflex/C cervical disc are second- generation, metal on metal designs intended to preserve motion with low wear. They feature a proprietary, straight-forward implant technique that includes specialized instruments for accurate placement. Both discs are currently approved for sale in South Africa, where they were developed.
"Our two U.S. clinical trials are progressing well and we are pleased with the early feedback," said David Hovda, President and CEO of SpinalMotion. "With Kineflex discs being implanted internationally for three years now, we are excited to be adding U.S. data to our worldwide clinical experience."
As reported earlier by SpinalMotion, the lumbar trial involves 25 U.S. sites. In this randomized study, the investigational SpinalMotion Kineflex(TM) lumbar disc is being compared to another FDA-approved lumbar artificial disc. The cervical trial involves 20 U.S. sites and features a randomized study comparing the investigational SpinalMotion Kineflex/C(TM) to fusion. Both trials are designed to demonstrate equivalent clinical success rates to their respective controls. A two-year follow-up period is planned for both trials.