MiMedx Group Receives FDA Clearance to Market Its HydroFix™ Ortho Shield™ 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 surgery, has now received clearance for an expanded range of sizes and for a higher temperature exposure limit. Additionally, a large animal implantation study has demonstrated the ability of the device to minimize soft tissue attachments between the device and the surrounding soft tissue.
Bill Taylor, President and COO, stated, "Receiving these additional FDA clearances for our HydroFix™ technology is an important step in serving the needs and preferences of physicians that are utilizing our device in their surgical procedures. Surgeon feedback has included requests for new indications for use and new sizes for existing indications, and these new 510(k) clearances are a direct result of a portion of that surgeon feedback. These FDA clearances are an integral part of our strategy of providing biomaterial solutions to unmet or underserved physician needs."
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