ALISO VIEJO, Calif.–(BUSINESS WIRE)–Medical device company Vertos Medical Inc. has announced the completion of enrollment in its post-market U.S. IRB (Institutional Review Board) I Patient Outcomes Trial, a 75-patient study of the mild* procedure. The open-label, single-arm, prospective, IRB-approved study is intended to gather patient outcomes data following treatment for symptomatic central canal spinal stenosis using proprietary mild devices. Results from the trial, which is being conducted by 14 investigators at academic and private practice settings across the United States, are expected to be published during 2010.
mild devices have been approved for commercial sale through the U.S. Food and Drug Administration’s 510(k) process. The company has begun training physicians to support the commercial launch of the mild procedure.
“I am very excited by the results we are seeing with the mild procedure, both from a safety and patient outcomes point of view,” said Bohdan Chopko, M.D., Ph.D., clinical faculty member at Northeastern Ohio Universities College of Medicine, practicing neurosurgeon and one of two medical monitors of the trial. “The mild devices have demonstrated an exceptional safety profile; patient feedback has been tremendous in regards to pain reduction and mobility improvement. As the scientific case for mild continues to build, I believe that physicians will embrace this new procedure as an important therapeutic alternative for a select and sizeable population of LSS patients.” Dr. Chopko shares Medical Monitor duties for the U.S. IRB I trial with David Caraway, M.D., Ph.D., a practicing pain physician at St. Mary’s Pain Relief Center, Huntington, W. Va.
In addition to the enrollment completion of its U.S. IRB I Trial of mild, Vertos has announced a comprehensive clinical program that currently includes the following seven additional post-market studies:
One 90-patient, multi-center safety study, the results of which have been submitted for publication
Two prospective, randomized clinical trials comparing mild to alternative therapies
Three single-institution prospective trials, and
A U.S. IRB II prospective, multi-center study
“My experience to date with the mild procedure has been very positive,” said Timothy Deer, M.D., practicing pain physician and the lead investigator of a prospective, single-center mild study at The Center for Pain Relief, Charleston, W. Va. “There have been no complications of any type, and no device-related adverse events. My patients are thrilled to have an option prior to undergoing larger, more invasive and more expensive open surgical techniques. The results thus far have been very exciting, and this is a major change in the spinal stenosis algorithm.”
Added James M. Corbett, president and chief executive officer of Vertos, “Completing enrollment in our U.S. IRB I Patient Outcomes Trial is a significant milestone for Vertos, as we are continuing to scientifically validate the clinical benefits of our ultra-minimally invasive mild approach. The trial’s successful enrollment and the fact that this is just one of a number of studies now underway on mild are indicative of the significant clinical interest in demonstrating and proving the procedure’s value at an earlier stage in the LSS progression.”
The first minimally invasive surgical treatment to provide immediate and lasting relief for patients by addressing a primary cause of lumbar spinal stenosis (LSS), mild was developed to provide a new option for patients who are no longer responding to pain medications and epidural steroid injections (ESIs) but who are not indicated for more invasive surgery. Vertos estimates that, at any given point in time, this patient population numbers more than 650,000.1 Treating LSS patients earlier and least invasively, which mild provides for, reduces overall health care costs.
About Vertos Medical Inc.
Vertos Medical was founded in 2005 to develop a minimally invasive method for lumbar spine decompression to treat patients with lumbar spinal stenosis (LSS), a degenerative, age-related narrowing of the lower spinal canal. Its first proprietary platform technology, called mild, is the least invasive surgical procedure for treating LSS, with no implants left behind. For more information, visit www.vertosmed.com.
* Vertos mild is FDA cleared for treating central canal stenosis of the lumbar spine.
1 Derived from the longitudinal CMS database
Vertos Medical Inc.
Laura Nobles, 310-795-0497