Integra LifeSciences Receives FDA Approvals for Three Spinal Fixation Devices
PLAINSBORO, N.J., April 11, 2011 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has received 510k clearance from the United States Food and Drug Administration (FDA) for three new spinal intervertebral body fusion devices (IBD), continuing to build its momentum in the spine market.
Each system was engineered to help simplify the surgical procedure and eliminate unnecessary steps. The new spinal fixation systems are the Cervical Stand-alone IBD, Vu cPOD™ Non-Strut IBD, and Steerable IBD. The systems are currently in limited commercial release and are targeted for full commercial release later this year.
IBDs are small hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and to allow fusion between vertebral bodies. These devices relieve pressure on the nerves and associated back pain by maintaining the natural disc space height and by providing positive mechanical stabilization of the vertebrae. The graft window in the device allows natural bone growth to occur through the IBD and form a strong vertebral union that incorporates the implant.
"This is a testament to Integra's engineering expertise, and a strong indication of our continued commitment to bring innovative solutions to market," states Brian Larkin, Integra's President, Global Spine and Orthobiologics, and Head of Strategic Development. "Our customers choose Integra because we are able to deliver quality medical devices through a collaborative approach with our surgeons."
Integra is also leveraging its considerable business development expertise by actively pursuing licensing deals, as evidenced by the recently announced exclusive licensing and development relationship between Stout Medical and Integra for a minimally invasive expandable interbody device. This effort, combined with our internal product development efforts, makes Integra uniquely positioned for growth.
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