MiMedx Group, an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, has received Class III certification for a European product using the company's proprietary HydroFix technology.
The certification for ‘post surgical adhesion inhibiting barriers’ is in addition to the MiMedx previous certification for HydroFix Spine Shield designated as a Class IIb device for use in certain locations along the anterior spine as a plane of dissection during revision surgery.
The new Class III certification is for use during posterior and anterior vertebral surgeries as a cover for the spine, including contact with the central nervous system (CNS) and central circulatory system (CCS), to provide a plane of dissection during revision surgery.
The HydroFix Spine Shield is a permanent and biocompatible implant which is suitable as an adhesion inhibiting barrier or plane of dissection between anatomical structures.
The proprietary and patented manufacturing process produces a product that is pliable, constructed in a single-layer and hydrophilic and the product may be trimmed and fitted easily at the time of use and may be sutured into place.
MiMedx chairman and CEO Parker Pete Petit said with the latest certification, they can begin to market HydroFix Spine Shield for use in posterior surgeries.
"This will allow us to serve the demand for post-surgical adhesion inhibiting barriers in the much broader posterior surgical market," Petit said.