Vertos Medical's Mild(R) Procedure Gets Nod From Leading Pain Medicine Physicians

Main Category: Neurology / Neuroscience
Also Included In: Pain / Anesthetics
Article Date: 06 Jul 2009 - 4:00 PDT

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Leading interventional pain physicians from key U.S. centers gathered at a special clinical symposium to share their experience with Vertos Medical's mild (Minimally Invasive Lumbar Decompression), the least invasive surgical procedure for treating lumbar spinal stenosis (LSS), with no implants left behind.* Their early clinical experiences suggest that mild may be an appropriate treatment alternative earlier in the LSS progression, as mild patients have shown favorable results when comparing post-treatment improvement at three months to open surgical procedure patient results at one year1. Moreover, mild leaves future surgical options open.

The June 29 symposium in Arlington, Va., was headlined by respected pain medicine experts Wade Wong, D.O., professor of Radiology and Anesthesiology and chief of Interventional and Spine Neuroradiology, University of California, San Diego; and Bohdan Chopko, M.D., Ph.D., clinical faculty member at Northeastern Ohio Universities College of Medicine and practicing neurosurgeon at Mid-Ohio Neurosurgical Care, Mansfield, Ohio. Symposium content included a mild clinical experience review, a didactic on mild patient selection and procedure execution, and a hands-on cadaver workshop.

Among the key data unveiled at the symposium were comparative Oswestry Disability Index (ODI) scores from an initial mild clinical study and from a published study on open surgical treatment for LSS. These data, presented by Dr. Chopko, indicated that mild patients showed excellent improvement at three months post-op compared to open surgery patients at 12 months post-op. mild patients also showed impressive improvement in Visual Analog Scale (VAS) scores at three months post-op.

"The early clinical data show that, with mild, LSS patients can achieve substantial relief earlier in the treatment cascade, before their condition degenerates to the point of requiring open surgery," said Dr. Chopko. "This is important news not only for patients but for the health care system, as treating patients earlier with mild is anticipated to produce significant cost savings over extended medical management and eventual open surgery."

Speaking about his early clinical experience with mild, Dr. Wong concluded that the procedure can be successfully performed on an outpatient basis under local anesthesia and light sedation, with average recovery at two to three hours. No procedural complications occurred.

"I am very encouraged by the preliminary patient outcomes with mild," said Dr. Wong. "My mild patients have been thrilled with their progress. One even played 18 rounds of golf just four days post-op. Prior to the mild procedure, his pain had rendered him nearly immobile."

Cleared by the U.S. Food and Drug Administration for decompression of the lumbar spine, mild is an image-guided procedure performed through a skin puncture the diameter of a pencil. Using proprietary mild devices, the physician removes the bone or tissue that is causing the pressure on the nerves.

Approximately 900,000 Americans are in some form of treatment for LSS every year2. Treating LSS patients earlier and least invasively, which mild provides for, reduces overall health care costs.

"We are gratified to have the enthusiastic support of some of the country's top pain physicians for our mild procedure," said James M. Corbett, president and chief executive officer of Vertos Medical. "We look forward to working with them to offer mild as a new and earlier treatment option for the hundreds of thousands of patients who needlessly suffer from LSS."

* Vertos mild is FDA cleared for treating central canal stenosis of the lumbar spine.

1 Weinstein, et al, for the SPORT Investigators. Surgical versus Nonsurgical Therapy for LSS. NEJM 2008;358:794-810

2 Derived from the longitudinal CMS database

Source
Vertos Medical Inc.