MiMedx Group has received CE Mark for its HydroFix Spine Shield device and was certified for design, development and production of post-surgical adhesion inhibiting barriers. The HydroFix Spine Shield is indicated for use in specific locations as a cover of the spine to provide a plane of dissection during a revision surgery.
The patented and biocompatible polyvinyl alcohol polymer (PVA) membrane may reduce the risk of injury that may be associated with anterior vertebral surgeries. By covering the spine at the surgical repair site in anterior spine surgeries, HydroFix Spine Shield creates a plane of dissection for revision surgeries.
The HydroFix Spine Shield is a permanent and biocompatible implant that is suitable as an adhesion inhibiting barrier or plane of dissection between anatomical structures. The patented manufacturing process produces a product that is pliable, constructed in a single-layer and hydrophilic. The product may be trimmed and fitted easily at the time of use and is sutured into place.
Rebeccah Brown, executive VP of product development, said: “Anterior spine surgery patients can require revision surgeries, during which these patients are exposed to significant risk. The HydroFix Spine Shield was designed to create a plane of dissection to help minimize risk during the revision surgery.”
Parker Petit, chairman, president and CEO, said: “This is the first MiMedx Group product to receive a CE Mark for commercial sale. The company’s strategy is focused on commercializing exciting new technologies, such as HydroFix Spine Shield, for orthopedic and other healthcare markets.
“Our focused development efforts include a number of advanced technology products that we plan to introduce worldwide following their progression through the clinical and regulatory clearance and approval processes.”