Healthcare Industry News:  transforaminal 

Devices Orthopaedic Neurosurgery FDA

 News Release - November 13, 2014

Integra LifeSciences Announces FDA Clearance and Controlled Market Release of Expandable Interbody System for Spinal Surgery

PLAINSBORO, N.J., Nov. 13, 2014 -- (Healthcare Sales & Marketing Network) -- Integra LifeSciences Holdings Corporation (IART) today announced the controlled market release of the Integra(R) Expandable Interbody System, in the United States. The system, which received 510(k) clearance from the United States Food and Drug Administration (FDA) earlier this year, is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). The device is intended for use with autogenous bone graft and supplemental fixation and can be used in either posterior or transforaminal lumbar interbody fusion procedures. These procedures are performed to help alleviate pain and nerve compression by fusing and stabilizing adjacent vertebrae in the lower back.

The Expandable Interbody System is designed to minimize the amount of implant insertion forces while achieving the patient-specific anatomical fit needed for proper treatment. Comprising an array of implant footprints, range of implant height expansions, and instrumentation, this system provides surgeons easy implantation with continuous in situ height expansion and, if necessary, the ability to reposition intraoperatively. Through a mechanical mechanism, the Expandable Interbody System allows for 50% expansion from its original starting height while maintaining a consistent graft aperture.

"We are very excited to introduce our first expandable interbody device," said Mark Augusti, Corporate Vice President and President of Orthopedics and Tissue Technologies. "This addition to our portfolio will cater to a vast group of spine surgeons performing posterior and transforaminal interbody fusions, including minimally invasive procedures. And with an in situ height expansion, the anatomical fit is tailored for each individual patient."

The Expandable Interbody System is another addition to the extensive Integra lumbar interbody portfolio. This product, coupled with Integra's expanding technology, positions the company to gain more market share in the evolving interbody market.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies, and spine hardware and orthobiologics. For more information, please visit

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, 2013 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Source: Integra LifeSciences

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