More than two million people in the U.S. each year are diagnosed with lumbar spinal stenosis (LSS), a degenerative, age-related narrowing of the lower spinal canal that leads to compression of the nerve roots. The symptoms of the disease include pain and numbness in the lower back, legs, or buttocks, which limits the patient’s ability to stand and walk. LSS treatments, historically, were limited to palliative therapies or invasive, high risk, open surgical procedures that result in changes to the structural stability of the spine. Resolving these challenges safely and effectively is California-based Vertos Medical that offers mild®—a clinically proven outpatient procedure that removes the cause of the stenosis, helping patients stand longer and walk further with less pain.
The mild procedure is done through a 5.1mm treatment portal and no general anesthesia, implants, or sutures are required. The procedure decompresses the spinal canal by removing small portions of bone overgrowth and debulking the thickened ligament, caused by the accumulation of inflammation-related scar tissue. “This is a simple, minimally invasive, low-risk pain therapy that directly treats the stenosis, has been shown to be as safe as a steroid injection, and provides long-term symptom relief,” explained Eric Wichems, President and CEO of Vertos Medical. Once the thickened ligament has been debulked, space is restored in the spinal canal and patients immediately experience a significant reduction in pain, and improvement in standing time and walking distance. “Unlike other more invasive procedures, patients can return home the same day and are generally able to resume light tasks and everyday activities within just a few days following the mild procedure,” he adds.
After the mild procedure, patients can return home the same day and are generally able to resume light tasks and everyday activities within just a few days
The mild procedure kit includes proprietary, patented medical instruments designed to access and debulk the bony structures and ligament causing the nerve impingement. The procedure can only be done by qualified physicians who have attended training provided by Vertos Medical. The key objectives of the training program are to establish clinical and technical comfort with the mild procedure through hands-on cadaveric lab practicum and physician-proctored didactics. Additionally, the training program focuses on identifying the right patient and acquiring a comprehensive understanding of the mild procedure and Level I clinical study data.
The mild procedure received national Medicare coverage in 2016, and has been used to treat more than 20,000 patients since its 2008 FDA clearance in the U.S. Its safety and efficacy have been demonstrated in more than 13 clinical studies and 20 articles. The mild data shows no device or procedure-related serious adverse events and a significantly lower rate of complications than other more invasive spine procedures. There are countless stories of patients who were not even able to stand, but are now hiking the mountains and can stand for hours. “If patients have the symptomology and the MRI confirms the thickened ligament, the mild procedure should be considered before more invasive options. Interested patients should always consult a doctor to determine if mild is the right treatment option for them,” Wichems mentions.
For Vertos Medical, the road ahead is quite clear, with the company’s focus on helping the large population of LSS patients in the U.S. However, it also aims to expand globally and treat patients from other parts of the world too. “We want to provide the mild procedure to as many patients as we can while growing and expanding as a company,” concludes Wichems.
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