PLAINSBORO, N.J., Apr 17, 2012 (GlobeNewswire via COMTEX) — Integra LifeSciences Holdings CorporationIART +2.21% today announced the United States full market release of the Integra(R) Vu aPOD(TM) Prime Intervertebral Body Fusion Device (IBD), expanding Integra’s spine product portfolio with the addition of its first zero-profile, stand-alone IBD designed for anterior lumbar fusion (ALIF) procedures. The Integra(R) Vu aPOD(TM) Prime IBD has received 510(k) clearance from the United States Food & Drug Administration (FDA), and will be featured at the American Association of Neurological Surgeons annual meeting, April 14 – 18, 2012, in Miami, Florida.
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 autogenous 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 the benefit of a zero-profile design by utilizing two screws 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 Vu aPOD(TM) Prime IBD is my go-to choice for ALIF procedures. I am able to pack a large amount of graft in the device, and the versatility of fixation is great for meeting anything I come up against in the OR,” said design surgeon, Andrew Parkinson, MD from Orthopedic Associates in Oklahoma City, Oklahoma.
The device was well received by surgeons throughout the controlled market release. “The Vu aPOD(TM) Prime device’s more rounded edge appears to reduce post-operative implant settling into the vertebral endplates,” said design surgeon, James Bruffey, MD from Scripps Clinic in San Diego, California.
Offering a wide variety of implant sizes, combined with a comprehensive set of instrumentation, the Integra(R) Vu aPOD(TM) Prime IBD is a less invasive alternative than the traditional anterior supplemental fixation implants with interbody construct used for ALIF procedures. Jaideep Chunduri, MD, a design surgeon from Beacon Orthopaedics and Sports Medicine in Cincinnati, Ohio said, “The versatility of the instrumentation for disc preparation and insertion allows for a wide range of options without the need for bulky guides.”
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.
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SOURCE: Integra LifeSciences Holdings Corp.