Collagen Matrix, Inc. Receives FDA 510(k) Clearance for DuraMatrix(TM) Collagen Dura Substitute Membrane
Collagen Matrix, Inc. is pleased to announce that it has received FDA’s 510(k) clearance of its DuraMatrix™ Collagen Dura Substitute Membrane.
Franklin Lakes, NJ (PRWEB) December 9, 2004 -- Collagen Matrix, Inc. is
pleased to announce that it has received FDA’s 510(k) clearance of its
DuraMatrix™ Collagen Dura Substitute Membrane. DuraMatrix is a safe, resorbable,
conformable, collagen-based membrane intended for use as a dura substitute in
the repair of dura mater.
Dura mater is the tough, fibrous membrane that
covers and protects the brain and spinal cord. When the dura mater is damaged
due to surgery or trauma, surgeons look to repair the injury with a dura
substitute material. Collagen Matrix has developed a collagen-based membrane
that possesses key characteristics of an ideal dura substitute that can be
implanted as an onlay graft or as a suturable graft. DuraMatrix is
biocompatible, resorbable, has a thickness similar to that of native dura, and
conforms to the contours of the brain. The unique conformability of the membrane
combined with its mechanical strength allows the membrane matrix to be implanted
with or without sutures. The characteristics of the device, including its pore
structure, are designed to aid and support the healing of the dura mater in
accordance with the accepted principle of guided tissue regeneration. DuraMatrix
is easy to handle and can be trimmed, either dry or hydrated, to fit the size of
the defect.
The safety and effectiveness of DuraMatrix are supported by a
clinical study and a large-scale animal study. The animal study, including 64
rabbits, was a comprehensive dural repair study comparing the effectiveness of
DuraMatrix with currently marketed collagen-based dural substitutes. DuraMatrix
was evaluated against DuraGen® Dural Repair Graft manufactured by Integra
LifeSciences and DuraGuard® Dural Repair Patch manufactured by Synovis Surgical
Innovations. DuraMatrix was the only dural substitute that demonstrated an
ability to facilitate the healing with balanced in vivo resorption of the device
and regeneration of host tissue. The clinical study confirmed the findings of
the animal study with no CSF leakage observed in any of the patients and no
device-related adverse effects reported.
“The FDA clearance of DuraMatrix
is a major milestone for Collagen Matrix. We expect this product to contribute
significantly to the growth of the Company in 2005,” said Shu-Tung Li, Ph.D.,
Founder and CEO of Collagen Matrix, Inc.
Collagen Matrix is launching
DuraMatrix and Neuroflex Flexible Collagen Nerve Cuff in the United States and
Europe through a network of independent distributors managed by Collagen
Solutions LLC, founded by Michael M. Bailey and Mark Roberson. Mr. Bailey,
President and CEO of Collagen Solutions, has over 23 years of experience in the
distribution of orthopedic and spine products. Through collaborations with key
orthopedic surgeons and neurosurgeons, Mr. Bailey has been an integral
contributor to the rapid growth of Blackstone Medical, Inc., a manufacturer and
supplier of devices and instruments for spinal surgery. Mark Roberson, Executive
Vice President of Sales, brings extensive experience in sales of medical
devices, including orthopedic, spine, and neurosurgical products. Through his
previous sales and management experience, Mr. Roberson has gained a strong
knowledge of the target market and has built relationships with key opinion
leaders in the field of neurosurgery. With a network of highly skilled
distributors in the neurosurgery field in the U.S. and Europe, Collagen Matrix
along with Collagen Solutions are well-positioned for the launch and anticipated
growth of product sales in the near future.
“We are very excited about
collaborating with Mike Bailey and Mark Roberson. Their combined experience and
track record of success are tremendous assets as we launch DuraMatrix and
Neuroflex globally,” added Shu-Tung Li, Ph.D.
Collagen Matrix, Inc. is a
leader in the design and engineer of collagen-based extracellular matrices for
tissue and organ repair and regeneration. Since its inception in 1997, the
Company has received many government grants for the development of innovative
collagen-based matrix products in the areas of neurological, vascular,
urological, and orthopedic tissue regeneration applications. The Company
currently manufactures collagen-based finished medical devices in the areas of
oral surgery and neurosurgery. More information about the Company can be found
at www.collagenmatrix.com.
Contact:
Shu-Tung Li, Ph.D.
201-405-1477
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Source : http://www.prweb.com/releases/2004/12/prweb186820.htm