New minimally invasive procedure successfully eliminates pain and disability caused by lumbar spinal stenosis

Jul 29 2008

Early clinical results from the US and Argentina reveal that a new minimally invasive procedure successfully eliminates pain and disability caused by lumbar spinal stenosis (LSS), a condition that, in severe form, can cripple sufferers.

Announced today at the Society of NeuroInterventional Surgery (SNIS) Annual Meeting in Lake Tahoe, Calif., these early results hold great promise for the nearly 1.5 million patients who are newly diagnosed each year and the neurointerventional practitioners committed to innovating new treatment options as alternatives to traditional surgery.

According to Joshua A. Hirsch, M.D., study presenter and Director of Interventional Neuroradiology/Endovascular Neurosurgery and Chief of Minimally Invasive Spine Surgery at Massachusetts General Hospital, the Minimally Invasive Lumbar Decompression (MILD) procedure offers patients that previously would have required open surgical treatment an efficacious alternative that can yield the same result with potentially fewer complications and a shorter recovery period. "The beauty of this procedure is that we have the opportunity to restore quality of life to hundreds of thousands of patients who are affected by LSS with an incision far smaller than a dime."

Lumbar stenosis is a narrowing of the spinal canal in the lower back, known as the lumbar area. This narrowing occurs when bone and/or ligament growth restricts the canal, squeezing and irritating the nerves that branch out from the spinal cord. This compression causes patients to experience low back pain, leg fatigue and pain, and, in severe cases, a significant reduced capacity for physical activity, including walking.

Designed to remove the bone and enlarged ligaments that compress the nerve roots, practitioners perform MILD using a recently-approved FDA device developed by Vertos Medical, Inc. of San Jose, Calif. This proprietary technology enables practitioners to first remove the bone -- known as a Laminotomy -- and then sculpt or thin the ligament.

To date, representatives of Vertos say that 42 patients have undergone the MILD procedure with no adverse events. Ten patients have been followed under an IRB-approved protocol designed to assess improvement of pain and disability with commonly used measurement instruments, as well as review narcotic intake. At six weeks post-treatment, the mean pain score decreased 90 percent and the mean disability score improved 84 percent, compared to baseline. Additionally, all 10 patients discontinued narcotics use for pain.

Performing the MILD procedure under radiological guidance, neurointerventional practitioners work through a metal tube -- or working cannula -- inserted through a small incision in the skin directly at the sight of the problem area. Physicians then place the Vertos device inside the cannula, applying it to the relevant bone and ligaments. Because this minimally invasive procedure allows practitioners to remove targeted portions of the bone, MILD has the advantage of protecting against the destabilization of the spine during the procedure. As with other minimally invasive treatments, patients also benefit from local anesthesia, as well as same- or next-day discharge.

According to Hirsch, like all new treatment options, the MILD procedure will continue to undergo further study to validate these initial promising results. If the procedure continues to yield the overwhelming success that it has thus far, Hirsch continues, MILD, like other now- established neurointerventional techniques, will become yet another driving force in the advancement of neurointerventional practice. "Compared to other disciplines, our field is still relatively young. But it is revolutionary therapies like this one that are giving neurointerventional practitioners the opportunity to change the entire landscape of patient care."