Lumbar spinal stenosis (LSS) is primarily a degenerative, age-related narrowing of the lower spinal canal that is diagnosed in more than 1.2 million individuals in the U.S. each year.3 Onset typically occurs after the age of 50. LSS symptoms include pain and numbness in the lower back, legs or buttocks, which limits the patient's ability to stand and walk.
The mild procedure treats LSS by removing hypertrophic ligamentum flavum, which helps restore space in the spinal canal. The restoration of space reduces pressure on the nerves, reduces pain, and improves mobility. The procedure is performed through a 5.1 mm treatment portal via a posterior approach using live fluoroscopy. This method and the mild instruments are designed to debulk tissue while maintaining the integrity of the ventral fibers of the ligamentum flavum by staying posterior to the thecal sac. The epidurogram is a key safety feature since it allows the physician constant visualization of the treatment area throughout the procedure. Another key safety feature is the minimally invasive design of the procedure itself, which requires no general anesthesia, no implants, no stitches, and is performed in about one hour.
mild has been performed on over 20,000 patients and has been proven to be safe and effective in 12 clinical studies and more than 20 peer-reviewed journal articles. Clinical trials that mild can help LSS patients stand longer and walk farther with less pain1 and no major device-related complications have been reported.2
Physicians are required to be certified to perform the mild procedure. Certification training is conducted at Vertos Medical's headquarters/training center in Aliso Viejo, CA, and includes sessions focused on patient selection, clinical data, and hands-on technique. Enrollment is limited; if you are interested in more information about the mild training program, please contact us.
To learn more about how mild helps LSS patients, click here.
Important Safety Information
Although the complication rate for the mild procedure is low, as with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest, stroke, and embolism. Other risks include infection and bleeding; spinal cord and nerve injury that can, in rare instances, cause paralysis. This procedure is not for everyone. Physicians should discuss potential risks with patients. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use.