PLAINSBORO, N.J., April 12, 2011 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market Accell Evo3® Demineralized Bone Matrix as a bone void filler product for use in the posterolateral spine.
In a pivotal animal study, Accell Evo3® Demineralized Bone Matrix demonstrated effective bone formation and achieved bilateral fusion at 12 weeks, when tested in the posterolateral rabbit spine model.�Radiographic, histologic and biomechanical analyses showed that Accell Evo3® Demineralized Bone Matrix performed as well as autograft, which served as the basis for the Pre-Market Notification decision.
Accell Evo3® Demineralized Bone Matrix is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure.�The product is indicated for use as a bone graft extender in the spine, extremities and pelvis.�Accell Evo3® Demineralized Bone Matrix may also be used as a bone void filler in the posterolateral spine, extremities and pelvis.�The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.�
“Integra is very pleased that the FDA cleared this new indication for Accell Evo3® Demineralized Bone Matrix,” said Bill Weber, Vice President and General Manager of Integra Orthobiologics.�”Surgeons must frequently obtain healthy bone graft material from the patient’s own body.�Accell Evo3® Demineralized Bone Matrix now offers them an alternative to harvesting the patient’s own bone, which may spare the patient additional surgeries and post-operative pain.”
Integra currently provides a complete range of bone graft substitutes to orthopedic surgeons and neurosurgeons, which includes Accell TBM®, Accell Evo3®, Accell Evo3®c, Accell Connexus®, DynaGraft®, and OrthoBlast® demineralized bone matrices, as well as the Integra MozaikTM line of products.
Integra LifeSciences, a world leader in medical devices, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care.� Integra offers innovative solutions in orthopedics, neurosurgery, spine, reconstructive and general surgery. For more information, please visit www.integralife.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.�Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra.�Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results.�Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures.�In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2010 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Integra LifeSciences Holdings Corporation
Gianna Sabella
Director, Corporate Communications
(609) 936-2389
gianna.sabella@integralife.com
http://bit.ly/he0Vx6
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