FDA Approved activL Could Replace Spinal Fusion
Photo Credit: Aesculap
Degeneration of the lumbar discs is responsible for 62 million annual physician visits in the United States and is the leading cause of chronic low back pain in adults.
For many of those adults, severe forms of lower back pain is a way of life and fusion surgery is traditionally recommended as a solution. Fusion fuses the vertebrae of the back together, alleviating the pain, but at the cost of reducing the movement in the treated area of the spine.
A newly FDA-approved spinal surgery procedure may provide a more favorable outcome to sufferers of severe back pain.
The activL Artificial Disc is designed to add more natural motion into a patient’s body. In clinical trials, the disc decreased the level of back pain severity, improved quality of life for patients and had a 90 percent patient satisfaction rate.
The activeL® Artificial Disc was approved by the U.S. Food and Drug Administration (FDA) in 2015.
The activL® Artificial Disc was designed in partnership with two U.S. orthopeadic surgeons backend by the same engineer expertise that had designed ProDisc-L (Aesculap, the activL manufacturer, actually sold ProDisc-L before designing activL).
At 5 years, activeL patients have 31% more range of motion – potentially because of its design features, which the company calls “Intelligent Motion Technology.”
The wear testing completed on the activL Artificial Disc is aggressive. It was tested out to 100 million cystle (validated to 80 years).
The artificial disc offers 4 degrees of freedom. The activL’s plastic insert permits motion at the treated level of the spine allowing it to move front to back within the metal endplates but not side to side.
The activL Artificial Disc has been in commercial use in Europe since 2005, with nearly 8,000 discs implanted to date. The commercial experience has been favorable with only four device explants, one device migration, and no device expulsions reported during this time, reported a study by James J. Yue, M.D., co-chief of the orthopaedic spine surgery section at the Yale School of Medicine.
If your doctor has recommended spinal fusion, consider seeking a second opinion, as artificial disc replacement has proven to eliminate motion restriction, be minimally invasive leading to faster recovery times, boasts low risk of degeneration, and is cost effective and safe.
You may be a candidate for artificial disc replacement surgery if you have the any of the following:
- Lower back pain with or without leg pain
- Degenerative disc disease
- Herniated lumbar discs
- Previous micro-discectomy surgery with continued pain
- Unsatisfactory results from conservative treatments
“If you have been told you need a spine fusion, you owe it to yourself to find out about artificial disc replacement,” said Dr. Jack Zigler, who has performed more than 2,000 disc replacement procedures with 14 different types of devices with his partners at Texas Back Institute. “There are less complications and more predictable outcomes.”
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