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Integra LifeSciences Holdings Corporation (IART) Receives FDA Clearance for Expanded Indication for Spinal Device


10/9/2012 7:29:28 AM

PLAINSBORO, N.J., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Integra(R) LifeSciences Holdings Corporation (IART) today announced that the Food and Drug Administration (FDA) has approved an expanded indication for use of the Integra(R) Vu aPOD(TM) Prime Intervertebral Body Fusion Device (IBD) in anterior lumbar interbody fusion (ALIF) procedures. The new stand-alone indication includes four points of fixation, which is composed of two screws and a SpinPlate(TM). The Integra(R) Vu aPOD(TM) Prime IBD will be featured at the Congress of Neurological Surgeons (CNS) annual meeting, October 6 -- 10, 2012, in Chicago, Illinois.

"Earlier this year the Vu aPOD(TM) Prime IBD entered its full market release with stand-alone indications," said Kirt Stephenson, President, U.S. Spine. "We're pleased that with this additional indication, we can now provide surgeons with multiple fixation options to best meet their patients' needs."

IBDs are designed to help provide stability for spinal fusion after a diseased lumbar disc is surgically removed. They are small, hollow spinal implants that are inserted into the intervertebral space to restore physiological disc height and allow fusion between vertebral bodies. These devices relieve pressure on the nerves and provide positive mechanical stabilization of the vertebrae. The graft window in the device is packed with bone and provides an environment in which natural bone growth can occur, which then enables fusion of the vertebral segments.

Traditionally, surgeons use supplemental fixation to help hold the IBD in place. However, the Integra(R) Vu aPOD(TM) Prime IBD features two zero-profile options utilizing two screws or two screws and a SpinPlate(TM) to help secure the IBD in its functional position, eliminating the need for supplemental fixation implants, and reducing the number of steps and implants required to perform an ALIF procedure.

"The Integra(R) Vu aPOD(TM) Prime IBD provides surgeons with an easy and safer approach when compared to other devices that have four points of fixation with four screws, and a very minimally invasive way to provide stability of the anterior lumbar spine, with no additional sharp objects introduced to the outside of the spine," said Jaideep Chunduri, MD, a design surgeon from Beacon Orthopaedics and Sports Medicine in Cincinnati, Ohio. "It is often difficult to place screws laterally within the lumbar spine. Integra's SpinPlate(TM), in conjunction with two screws, enables four-point fixation without significant retraction. Because the SpinPlate(TM) is also located within the middle of the device, and provides built-in fixation, there is no added risk in terms of blood loss or vascular tissue. "

Integra is a leading provider of implants and orthobiologics used in spinal surgery. Integra's lumbar interbody portfolio also includes the Hollywood(TM) IBD, Pacifica(TM) IBD, Redondo(TM) IBD, Ventura(TM) IBD, Vu ePOD(TM) IBD, Vu LPOD(TM) IBD and the Zuma(TM) fixation system.

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, 2011 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



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