Back Pain Treatment Called mild® Cleared for European Use
ALISO VIEJO, Calif., Oct. 30, 2012 /PRNewswire/ -- The mild® procedure, an innovative outpatient back-pain treatment from Vertos Medical Inc., has received approval to be marketed and sold throughout Europe. Vertos received the CE Mark this summer, which signifies that it has complied with all legal and safety requirements to sell its mild device kit in the 30 countries of the European Economic Area (27 European Union countries and 3 European Free Trade Association countries) plus Switzerland.
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 due to age and deterioration. Since the Food and Drug Administration's 510(k) clearance of mild in 2008, more than 12,000 people have received the treatment in the U.S.
Vertos Medical CEO James Corbett said the issuance of the CE Mark was great news for patients suffering from LSS in Europe. Corbett said: "mild has been proven safe and effective in the U.S. We are excited to be one step closer to bringing mild to the European market where we know there is a great deal of pent up demand for it. mild has helped thousands of patients stand longer and walk farther with less pain in the U.S. It will surely do the same for patients in Europe."
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. 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 percent1.
The results are often dramatic. According to a recent study, mild is both effective and efficient and gives many LSS patients an exciting new alternative to open back surgery. The study concluded that mild provides both pain relief and an improved quality of life. Ten other studies and 12 additional published peer-reviewed journal articles mirror these findings. mild patients are experiencing positive effects. To read patients' stories and find more information about mild, please visit www.Vertosmed.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.
1Data 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.