Spinal stenosis future or investigational therapies
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
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Overview
Future or Investigational Therapies
Recent developments include several new implants used in surgery to treat the symptoms of spinal stenosis, while preserving as much normal motion in the spine as possible. The only FDA approved non-fusion treatment is the X STOP, which works via indirect decompression, called Interspinous Process Decompression (IPD) Some other IPD technologies that are still being studied include the Wallis implant, the DIAM and the Coflex. Other implant systems being studied include the Dynesys, the Stabilimax, the TFAS and the Anatomic Facet Replacement System.
In November 2005 the X-STOP was approved by the FDA for treatment of lumbar spinal stenosis with moderate symptoms. This procedure is a much less invasive surgery than decompression, but the treatment is still new and effectiveness, indications and potential risks and complications won't be well understood until the procedure has been in use for a longer period.
One recent implant system that was being studied in the US reportedly has problems that ended its enrollment, the TOPS implant. This was reported by an investor in Impliant.
Also recently, non-fusion implant was recalled officially in the United Kingdom, though in the US the device has been withdrawn from surgeons but MDT has not issued a recall, probably due to the way inventory is handled rather than a difference in the product sold in the US vs. the UK.