Long Term Safety & Effectiveness of Back Treatment Called mild® Demonstrated in New Systematic Safety Review
ALISO VIEJO, Calif., Dec. 5, 2012 /PRNewswire/ -- The following is being released by Vertos Medical Inc.
The mild® procedure, a minimally-invasive outpatient procedure designed to provide relief to patients suffering with a common back condition, lumbar spinal stenosis (LSS), is safe and effective over the long term, according to a new comprehensive review published in the American Academy of Pain Medicine's Pain Medicine Journal. The review by Drs. Robert M. Levy MD, PhD and Timothy Deer MD, examined the impact of mild in eight separate studies conducted at 32 sites across the U.S. and Canada.1 The mild procedure was shown throughout to be safe and to alleviate pain and improve mobility over a long period for patients suffering with LSS.
According to the review, "There were no reports of major device- or procedure-related adverse events" in any of the 373 clinical study patients. The procedure did not require general anesthesia or stitches and was performed through a very small incision (5.1 mm, or about the size of a baby aspirin). None of the patients stayed in a hospital more than 24 hours and the procedures were completed in about an hour. The review also found that mild patients did not suffer the kinds of major complications that are associated with other minimally-invasive LSS treatments such as microscopic or endoscopic procedures.
The review established that the effects of mild are durable. Study patients were followed for anywhere between 12 weeks to over a year post procedure. 134 of these patients had data collected at one year and this data demonstrated that more than eighty percent of the participants experienced significant improvement in mobility and reduction in pain.2 These findings further support the positive long term data published in a recent study, which showed an average standing time improvement from 8 minutes pretreatment to nearly an hour at one year after the mild procedure and an average walking distance improvement from 246 feet pretreatment to nearly three quarters of a mile at one year after the mild procedure.
LSS is caused by the compression of the nerves in the spinal canal, leading to pain and numbness in the lower back, buttocks and legs as well as reduced mobility. The review states that more than five million Americans suffer from LSS and that number is expected to rise as the population ages. The Pain Medicine article noted that the likely increase in LSS patients means alternative therapies such as mild will be essential to meeting their needs in a timely, safe and cost effective way. "Given the societal aging trend, utilization of this technology will likely grow to include even larger numbers of individuals and can be projected to yield meaningful savings in health care costs," according to Drs. Levy and Deer.
Multiple studies have confirmed that mild patients are experiencing positive effects with a low risk of major complications. To read patients' stories and find more information about mild, please visit www.mildprocedure.com.
mild® is a 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 15 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.
1Levy, Robert, et al. (2012), Systematic Safety Review and Meta-Analysis of Procedural Experience Using Percutaneous Access to Treat Symptomatic Lumbar Spinal Stenosis. Pain Medicine, doi: 10.1111/j.1526-4637.2012.01504.x
2 Year one population (134 patients) had a 3.9 mean VAS improvement and a 16.0 mean ODI improvement.
SOURCE Vertos Medical Inc.