MiMedx Group Receives FDA Clearance to Market Its HydroFixâ„¢ Ortho Shieldâ„¢ Device
MARIETTA, Ga., June 22, 2011 /PRNewswire/ -- MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials including bioimplants processed from human amniotic membrane, announced today that the Company's proprietary device, HydroFix™ Ortho Shield™, has received 510(k) clearance. The Company also announced its receipt of two additional 510(k) clearances related to its HydroFix™ technology platform.
HydroFix™ Ortho Shield™ 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 is indicated to minimize tissue attachment to the device in case of direct contact with the tissues. HydroFix™ Ortho Shield™ is a permanent protective sheet that minimizes soft tissue attachments to the device providing a protective environment for the repaired tendon to heal. The device is conformable, suturable, and biocompatible, providing surgeons with an easy to use option for tendon protection. The device also provides a smooth inner gliding surface for the tendon to move as part of normal motion.
Parker H. "Pete" Petit, Chairman and CEO, said, "We are pleased to receive these FDA clearances. Soft tissue attachments to repaired tendons can reduce the effectiveness of the repair and result in a reduced range of motion post surgery, so the HydroFix™ Ortho Shield™ meets an important clinical need. We are continuing to develop additional indications for this biomaterial in response to surgeon demand for a wide range of applications."
The two additional 510(K) clearances recently received from the FDA were for the Company's HydroFix™ Vaso Shield device. HydroFix™ Vaso Shield, indicated for use as a cover for vessels during anterior vertebral surger