Integra LifeSciences Receives FDA Clearance for Multiple Fixation Options for Vu aPOD(TM) Prime ALIF Device
PLAINSBORO, N.J., Oct. 6, 2010 (GLOBE NEWSWIRE) -- Integra LifeSciences (Nasdaq:IART) announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Vu aPOD™ Prime anterior lumbar interbody fusion (ALIF) device.
ALIF is a procedure used in the treatment of back pain of discogenic origin. The procedure's goal is to fuse vertebrae and reduce pain. A surgeon approaches the spine through an incision in the abdomen, removes a disc in the lower spine, and may replace it with an interbody device. Additional fixation may be required.
The Vu aPOD™ Prime allows for two fixation options. It can be secured in place with two self-tapping bone screws, requiring no additional supplemental fixation and dramatically reducing the number of operative steps when compared with other ALIF implants. Alternatively, the Vu aPOD™ Prime may be secured with SpinPlateTM internal buttress plate technology, which requires supplemental fixation. Its anatomic shape and large graft window also help facilitate fusion.
"The new Vu aPOD™ Prime represents Integra's latest success in delivering innovative products to the spine community," states Brian M. Larkin, President, Global Spine and Orthobiologics and Head of Strategic Development for Integra. "When used with the two bone screws, The Vu aPOD™ Prime provides an advantage to the surgeon to be able to offer an ALIF intervertebral body fusion device as a stand-alone device, meaning it requires no additional supplemental fixation. This streamlines the technique, which in turn may help reduce the OR time and implants required to perform this procedure."
The ALIF U.S. market size is estimated to be $425M in 2010. ALIF procedures are most common in the L4-L5/S1 region of the spine for correction of degenerative disc disease (DDD).
Integra will be showcasing the Vu aPOD™ Prime device as a feature product at the upcoming North American Spine Society (NASS) Annual Meeting in Orlando, Florida. Dr. James Bruffey (Scripps Clinic Torrey Pines, La Jolla, California) and Dr. Andrew Parkinson (Orthopedic Associates, Oklahoma City, Oklahoma) will be performing live product demonstrations in the booth on October 6th and 7th at 12:30PM and 4PM respectively.
Integra Spine is a leading provider of fusion implants and orthobiologics used in spinal surgery. Visit www.integralife.com for more information.
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 future use of the Vu aPOD™ Prime system. 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 physicians to use this products may affect the prospects for its use in clinical 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, 2009 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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