MiMedx Group has received the US Food and Drug Administration (FDA) approval for HydroFix Ortho Shield which is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
The patented HydroFix Ortho Shield is a biocompatible polyvinyl alcohol polymer (PVA) membrane that minimizes soft tissue attachments to the device providing a protective environment for the repaired tendon to heal.
The company also received two additional 510(k) clearances for HydroFix Vaso Shield device.
HydroFix Vaso Shield is indicated for use as a cover for vessels during anterior vertebral surgery.
MiMedx chairman and CEO Parker Petit said smooth inner gliding surface attachments to repaired tendons can reduce the effectiveness of the repair and result in a reduced range of motion post surgery.
MiMedx president and COO Bill Taylor said receiving these additional FDA clearances for HydroFix technology serves the needs and preferences of physicians that are utilizing their device in their surgical procedures.