Health Problem: Lumbar spinal stenosis (LSS) affects more than 200,000 adults in the United States and is a source of substantial pain and disability. Major contributors to LSS include degenerative intervertebral discs and bone structures, as well as hypertrophy of the ligamentum flavum.

Technology Description: The mild device kit (Vertos Medical Inc.) is a sterile, single-use system of surgical instruments. The mild procedure is a minimally invasive, image-guided, posterior spinal procedure that increases the dimensions of the spinal canal by achieving nerve decompression via the debulking of the hypertrophied ligamentum flavum or small amounts of the lamina. The mild procedure is performed under local anesthesia and light sedation and typically is a same-day surgery. No implant is used in the procedure.

Controversy: The standard treatment of LSS that has failed conservative management is conventional open decompression alone or with spinal fusion. Conventional microdiscectomy or open surgery is performed under general anesthesia; usually requires inpatient hospitalization; an incision size of 4 to 6 centimeters; and has associated risks of worsened instability, nerve injury, nonunion, adjacent segment degeneration, and intraoperative blood loss. Less invasive procedures have been developed; however, these procedures still require general anesthesia and often inpatient hospitalization.

Key Questions:

  • Is the Vertos mild procedure effective in treating LSS with neurogenic claudication primarily due to ligamentum flavum hypertrophy?
  • How does the Vertos mild procedure compare with clinical alternatives for treatment of LSS?
  • Is the Vertos mild procedure safe?
  • Have definitive patient selection criteria been identified for the Vertos mild procedure?

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