Clinical Studies on the mild® Procedure
Comprehensive clinical studies, covering 542 patients enrolled in 11 clinical studies, have been performed at leading institutions to validate the safety and effectiveness of the mild® procedure. Clinical studies prove that the mild® procedure is a safe procedure that can help LSS patients stand longer and walk farther with less pain.1 No major device-related complications have been reported in all clinical studies.2
Clinical studies have shown that 79% of patients experienced a 53% reduction in pain and a 34% increase in mobility one year after having the mild® procedure.3
A clinical study, performed at one of the top academic medical centers in the United States, showed that the mild® procedure significantly improved the quality of life of patients as measured by improvements in the amount of time they could stand and distance they could walk one year after having the procedure.1
- Standing time improved from 8 minutes before the mild® procedure to 56 minutes after the mild® procedure.1
- Walking distance improved from 246 feet before the mild® procedure to 3,956 feet after the mild® procedure.1
Thousands of patients have undergone the mild® procedure nationwide. Find a doctor certified to perform the mild® procedure in your area.
Important Safety Information
The mild® procedure is intended to treat lumbar spinal stenosis caused by ligamentum flavum hypertrophy. The procedure is performed using specialized surgical instruments indicated for use in lumbar decompressive procedures. This procedure is not for everyone. There are risks associated with lumbar surgery and serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood or fat that migrates to the lungs or heart). Other risks include infection and bleeding; spinal cord and nerve injury that can, in rare instances, cause paralysis. Please consult your doctor for a discussion of benefits and risks and whether this procedure is right for you.
1 Mekhail, Nagy, et al. (2012), Functional and Patient-Reported Outcomes in Symptomatic
Lumbar Spinal Stenosis Following Percutaneous Decompression. Pain Practice, 12(6):
417–425. doi: 10.1111/j.1533-2500.2012.00565.x
2 Based on mild procedure data collected in all clinical studies. Major complications are defined
as dural tear and blood loss requiring transfusion.
3 American Society of Regional Anesthesia & Pain Medicine presentation, 2011 Annual Meeting.