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
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