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New Minimally Invasive Surgical Procedure Restores Quality of Life in Patients With Potentially Debilitating Spinal Condition

Wednesday, July 30, 2008 General News
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LAKE TAHOE, Calif., July 29 Early clinical results fromthe US and Argentina reveal that a new minimally invasive proceduresuccessfully eliminates pain and disability caused by lumbar spinal stenosis(LSS), a condition that, in severe form, can cripple sufferers. Announcedtoday at the Society of NeuroInterventional Surgery (SNIS) Annual Meeting inLake Tahoe, Calif., these early results hold great promise for the nearly 1.5million patients who are newly diagnosed each year and the neurointerventionalpractitioners committed to innovating new treatment options as alternatives totraditional surgery.
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According to Joshua A. Hirsch, M.D., study presenter and Director ofInterventional Neuroradiology/Endovascular Neurosurgery and Chief of MinimallyInvasive Spine Surgery at Massachusetts General Hospital, the MinimallyInvasive Lumbar Decompression (MILD(TM)) procedure offers patients thatpreviously would have required open surgical treatment an efficaciousalternative that can yield the same result with potentially fewercomplications and a shorter recovery period. "The beauty of this procedure isthat we have the opportunity to restore quality of life to hundreds ofthousands of patients who are affected by LSS with an incision far smallerthan a dime."
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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 ligamentgrowth restricts the canal, squeezing and irritating the nerves that branchout from the spinal cord. This compression causes patients to experience lowback pain, leg fatigue and pain, and, in severe cases, a significant reducedcapacity for physical activity, including walking.

Designed to remove the bone and enlarged ligaments that compress the nerveroots, practitioners perform MILD(TM) using a recently-approved FDA devicedeveloped by Vertos Medical, Inc. of San Jose, Calif. This proprietarytechnology enables practitioners to first remove the bone -- known as aLaminotomy -- and then sculpt or thin the ligament.

To date, representatives of Vertos say that 42 patients have undergone theMILD(TM) procedure with no adverse events. Ten patients have been followedunder an IRB-approved protocol designed to assess improvement of pain anddisability with commonly used measurement instruments, as well as reviewnarcotic intake. At six weeks post-treatment, the mean pain score decreased90 percent and the mean disability score improved 84 percent, compared tobaseline. Additionally, all 10 patients discontinued narcotics use for pain.

Performing the MILD(TM) procedure under radiological guidance,neurointerventional practitioners work through a metal tube -- or workingcannula -- inserted through a small incision in the skin directly at the sightof the problem area. Physicians then place the Vertos device inside thecannula, applying it to the relevant bone and ligaments. Because thisminimally invasive procedure allows practitioners to remove targeted portionsof the bone, MILD(TM) has the advantage of protecting against thedestabilization of the spine during the procedure. As with other minimallyinvasive treatments, patients also benefit from local anesthesia, as well assame- or next-day discharge.

According to Hirsch, like all new treatment options, the MILD(TM)procedure will continue to undergo further study to validate these initialpromising results. If the procedure continues to yield the overwhelmingsuccess that it has thus far, Hirsch continues, MILD(TM), like other now-established neurointerventional techniques, will become yet another drivingforce in the advancement of neurointerventional practice. "Compared to otherdisciplines, our field is still relatively young. But it is revolutionarytherapies like this one that are giving neurointerventional practitioners theopportunity to change the entire landscape of patient care."

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