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.
“I am very excited by the results we are seeing with the mild procedure,
both from a safety and patient outcomes point of view”
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: