PLAINSBORO, N.J., Jun 8, 2010 (GlobeNewswire via COMTEX) — Integra LifeSciences(IART 37.91, +0.05, +0.13%) announced today a major milestone in the commercialization of the Vu a-POD(TM) anterior lumbar intervertebral body fusion (ALIF) device. Launched in the U.S. in early 2009, the Vu a-Pod(TM) fusion device has now been implanted in over 800 patients in the U.S.
With required secondary fixation, the first-to-market, innovative SpinPlate(TM) technology of the Vu a-Pod(TM) fusion device provides an internal locking mechanism that enhances implant stability and reduces the risk of unintended implant expulsion. The Vu a-POD(TM) fusion device also offers a large graft window that allows a substantial quantity of bone graft to be packed within the implant to promote autogenous bone fusion and further enhance stability.
Since the introduction of the Vu a-POD(TM) fusion device, the innovative SpinPlate(TM) technology has been widely adopted. Integra plans to continue its commercialization in the U.S. and expand its distribution to include international sites.
Dr. James Bruffey, Scripps Clinic – Torrey Pines, La Jolla, CA, the surgeon inventor for the Vu a-POD(TM) fusion device, states, “I have almost two years of clinical experience with the Vu a-POD(TM) fusion device and SpinPlate(TM). The footprint and lordosis options available for the PEEK implant have allowed me to optimize graft placement and position for a variety of patient pathologies. The SpinPlate(TM) is simple, safe, and secure. It holds the implant at the point of placement, which I think has optimized its clinical performance. Fusion rates have been extremely high, and I have noted very few problems with implant subsidence and no issues with implant migration. The simplicity of the SpinPlate(TM) has dramatically reduced operative times, and the true zero-profile nature of the implant has resulted in no intraoperative or postoperative vascular injury issues.”
“ALIF devices with integrated screws require additional exposure and may present challenges with screw insertion at difficult angles. The straight approach of Vu a-POD(TM) fusion device allows me to perform the same ALIF surgery with less exposure for the patient and potentially less risk to the great vessels,” states Dr. Jaideep Chunduri, Beacon Orthopaedics, Sharonville, OH, a design surgeon for the Vu a-POD fusion device.
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).
The Vu a-POD(TM) fusion device is distributed by Integra Spine’s independent distributor network. Integra Spine is a leading provider of fusion implants and orthobiologics used in spinal surgery. Visit www.integraspine.com for more information.
Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is a global medical device company dedicated to improving the quality of life for millions of patients every year. The company’s products are used primarily in orthopedics, neurosurgery and general surgery. Headquartered in Plainsboro, New Jersey, Integra has research and manufacturing facilities throughout the world. For more information visit www.integra-ls.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 a-POD(TM) fusion device. 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 product 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.
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SOURCE: Integra LifeSciences Holdings Corp.