12,000 Patients Treated; Cleveland Clinic Study Documents Effectiveness
ALISO VIEJO, Calif., Oct. 17, 2012 /PRNewswire-USNewswire/ -- The mild® procedure, an innovative outpatient back-pain treatment, has passed a major milestone – more than 12,000 patients have received the treatment across the U.S.
In addition, a growing number of clinical studies, including a recent trial published by the prestigious Cleveland Clinic, show that mild helps patients stand longer and walk farther with less pain over an extended period.
The mild procedure alleviates pain and increases mobility for patients suffering from lumbar spinal stenosis (LSS), which is caused by a narrowing of the spinal column caused by age and deterioration. Since the FDA's 510(k) clearance of mild in 2008, more than 12,000 people have benefited from the procedure.
Multiple trials, including one by the Cleveland Clinic earlier this year, provide significant evidence of mild's long-term effectiveness. The study demonstrated that mild is a safe, efficient treatment that is helping LSS patients go on with their daily lives.
The mild procedure is designed to provide relief to patients suffering from LSS in a minimally invasive way. LSS is caused by the compression of the nerves in the spinal canal known as neurogenic claudication. This condition leads to pain and numbness in the lower back, buttocks, or upper legs as well as reduced mobility. mild alleviates the compression by restoring space in the spinal canal with precision instruments through an incision the size of a baby aspirin. The procedure is performed on an outpatient basis, does not require general anesthesia or stitches and has a positive response rate of nearly 80 percent (1).
The results are often dramatic. According to the Cleveland Clinic study, mild is both effective and efficient and gives certain LSS patients an exciting new alternative to open back surgery. After monitoring 40 patients over a one-year, post-treatment period, researchers found that standing time for mild patients increased on average from eight minutes to nearly an hour and that the patients' average walking distance increased from 246 feet to nearly three quarters of a mile. The study concluded that mild provides both relief and an improved quality of life.
"This study demonstrated significant functional improvement as well as decreased disability secondary to neurogenic claudication at 1 year following percutaneous lumbar decompression," the study states. "There were no significant device or procedure-related adverse events reported in this study."
Ten other studies and eleven published peer-reviewed journal articles mirror the findings of the researchers at the Cleveland Clinic. More and more LSS patients are receiving the mild treatment and seeing their quality of life improve. Whether it is enjoying a hike or performing everyday tasks like grocery shopping, mild patients are experiencing the positive effects of the procedure and telling their stories. To read these stories and find more information about mild, please visit www.mildprocedure.com.
mild® is an extremely safe procedure that can help patients diagnosed with lumbar spinal stenosis (LSS) stand longer and walk farther with less pain. It is a short outpatient procedure performed through an incision the size of a baby aspirin that requires no general anesthesia, no implants and no stitches. Its efficacy and safety have been demonstrated in 11 clinical trials and 12 physician reviewed clinical journal articles. For more information, visit www.mildprocedure.com.
About Vertos Medical, Inc.
Vertos Medical is a leader in the treatment of patients suffering with lumbar spinal stenosis (LSS), a degenerative, age-related narrowing of the lower spinal canal. Its proprietary technologies include mild®, which offers an outpatient, minimally invasive, fluoroscopically guided therapeutic treatment of LSS. For more information, visit www.vertosmed.com.
(1) Data based on 'responder' group in MiDAS I study at one year. Responders defined by > 1 point VAS improvement. At one year, 79% of all patients were 'responders.'
SOURCE Vertos Medical, Inc.