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The Swedish Neuroscience Institute is one of only a few U.S. centers involved in two clinical trials designed to prove the safety and effectiveness of a new artificial disc.
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The prosthetic disc is designed to help people with degenerative disc disease maintain their neck mobility after surgery.
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Swedish is home to one of the country’s most advanced artificial spinal disc implant programs.
Swedish a leader in innovative solutions for spinal pain
The Swedish Neuroscience Institute is one of only 25 centers in the United States participating in clinical trials designed to prove the safety and effectiveness of a new artificial disc. The goal is to help people with degenerative disc disease maintain their mobility.
Degenerative disc disease refers to a loss of cushioning in the spinal discs, which are the spongy parts between the bones in the neck. It’s a common condition caused by the normal wear and tear of aging.
The discs in the spine act as cushions and shock absorbers, allowing you to move your neck. “Many people don’t realize that,” says Rod Oskouian, M.D., a neurosurgeon at Swedish Neuroscience Institute who specializes in diagnosing and treating complex spinal disorders. “But when they lose the disc’s cushion, they start to experience pain.”
In the last decade or two, artificial disc replacement for the spine has been “a game changer” for people with degenerative disc disease, Dr. Oskouian says. These types of procedures involve replacing a patient’s natural disc with an artificial one.
Before artificial discs were available, surgeons would perform spinal fusions on patients with degenerative disc disease, which essentially took their neck mobility away, he adds.
Although fusions are still needed to treat certain conditions, like severe cases of spinal stenosis (spinal narrowing) and spondylolisthesis (spinal instability), artificial disc technology has made them unnecessary for more routine surgeries, like those to treat degenerative disc disease.
But not every center has the technology.
The Swedish Neuroscience Institute is one of the most active centers in the country to offer artificial disc implants, Dr. Oskouian says: “As an academic spine program, we are constantly involved in innovative clinical trials like these that are designed to bring new technologies to market.”
Bringing the technology to market
The artificial disc under investigation in the clinical trials, called the BAGUERA®C Cervical Disc Prosthesis, is designed to mimic the natural biomechanical properties of a healthy person’s disc — and is engineered to maintain and restore the disc’s natural alignment and mobility.
BAGUERA®C has been available in countries around the world since 2008 — but not the United States. The two clinical trials will compare the safety and effectiveness of BAGUERA®C to an artificial disc implant already approved by the Food and Drug Administration (FDA) for use in U.S. patients.
The first clinical trial is focused on patients with single-level cervical disc disease, or wear and tear resulting in disease between the C3 and C7 vertebrae. The second trial is studying the success rate of the artificial disc in patients with disease in two levels between these vertebrae.
Enrollment for both clinical trials is complete, with a total of 600 patients participating.
All patients enrolled in the study:
- Are between the ages of 22 and 69.
- Have degenerative disc disease at one or two levels in their neck.
- Have been unresponsive to conservative treatments for at least six weeks.
- Have no prior history of surgical treatment at any level of their cervical spine.
The trials are multicenter and prospective, meaning patients are followed over time. In this case, patients are followed for two years after surgery to measure the devices’ safety and effectiveness. The trials are also randomized, meaning patients are randomly assigned either the BAGUERA®C device or the FDA-approved disc implant.
The results will help determine whether the BAGUERA®C device receives FDA approval. At the earliest, the device could receive pre-market approval from the FDA in late 2026.
“This disc has been implanted in more than 35,000 patients in more than 40 countries outside of the United States, so there’s a lot of clinical evidence already supporting it,” Dr. Oskouian says. “The technology is just incredible. That’s why we’re excited to be involved in these trials, so we can help get this artificial disc to patients.”
Learn more and find a provider
Our Swedish spine specialists offer exceptional care and ongoing, compassionate support to help treat neck, back and spinal cord conditions and improve your quality of life. We have nationally recognized surgeons, as well as nurse practitioners, physician assistants and registered nurses, to provide you not only with advanced interventional and surgical care but a range of education and support services.
Contact us to learn more or request an appointment. You can also use our provider directory to find a specialist close to you.
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This information is not intended as a substitute for professional medical care. Always follow your health care professional's instructions.
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