Focus of the Report: The focus of this Health Technology Assessment is to evaluate the effectiveness and safety of the minimally invasive lumbar decompression (mild) procedure, an approach that uses a proprietary surgical kit (mild; Vertos Medical Inc.) to treat lumbar spinal stenosis (LSS) in adult (≥ 18 years old) patients.

Technology Description: The mild procedure is a minimally invasive spine surgery that increases the dimensions of the spinal canal by debulking the hypertrophied ligamentum flavum (HLF) and possibly small amounts of the lamina, thereby achieving nerve or canal decompression. The procedure is fluoroscopically guided, and the surgeon uses a small portal to access the spine.

Controversy: Although the Vertos mild procedure involves only local anesthesia and a small incision, there are uncertainties related to how it compares with other minimally invasive procedures, the durability of effect, patient selection criteria, and whether the procedure is cost-effective.

Key Questions:

  • Is the Vertos mild device and associated procedure effective for treating LSS primarily due to HLF in adult patients?

  • How does the Vertos mild procedure compare with clinical alternatives for the treatment of LSS due to HLF?

  • Is the Vertos mild procedure in patients with LSS primarily due to HLF safe?

  • Have definitive patient selection criteria been identified for the Vertos mild device kit and associated procedure in patients with LSS primarily due to HLF?

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