Business Wire06.15.17
DJO Global Inc., a global provider of medical technologies designed to get and keep people moving, announced the onset of a clinical trial for a new indication of the CMF OL1000 Bone Growth Stimulator.
Combined Magnetic Field (CMF) devices have been on the market since the early 1990s, providing medical professionals with a tool for the noninvasive treatment of an established non-union fracture acquired secondary to trauma, excluding all vertebrae and flat bones. Due to the type of signal technology, CMF devices are prescribed for a treatment time of 30-minutes per day. These battery-powered, FDA-approved medical devices can be used in conjunction with non-magnetic internal or external fixation, over a cast or brace.
DJO Global, through its subsidiary, Encore Medical L.P., initiated the application for an Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA) for a new indication of the CMF technology into the fresh fracture market. The prospective, randomized, double-blinded, controlled, multi-center clinical study will evaluate the use of the CMF OL1000 as a noninvasive adjunctive treatment for closed, unstable ankle fractures that require surgical treatment for stabilization. The FDA-approved study initiated enrollment in January of this year.
Find more information on the study here.
Combined Magnetic Field (CMF) devices have been on the market since the early 1990s, providing medical professionals with a tool for the noninvasive treatment of an established non-union fracture acquired secondary to trauma, excluding all vertebrae and flat bones. Due to the type of signal technology, CMF devices are prescribed for a treatment time of 30-minutes per day. These battery-powered, FDA-approved medical devices can be used in conjunction with non-magnetic internal or external fixation, over a cast or brace.
DJO Global, through its subsidiary, Encore Medical L.P., initiated the application for an Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA) for a new indication of the CMF technology into the fresh fracture market. The prospective, randomized, double-blinded, controlled, multi-center clinical study will evaluate the use of the CMF OL1000 as a noninvasive adjunctive treatment for closed, unstable ankle fractures that require surgical treatment for stabilization. The FDA-approved study initiated enrollment in January of this year.
Find more information on the study here.