Integra LifeSciences Expands Shoulder Product Line With the Introduction of a Proximal Humeral Fracture Plate System
PLAINSBORO, N.J., March 20, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Integra® Proximal Humeral Fracture Plate System received 510k clearance from the U.S. Food and Drug Administration (FDA), and expects to begin a controlled market release in 2013. It is the latest addition to Integra's growing shoulder product line and complements the Integra Titan™ Shoulder portfolio by offering treatment options for proximal humeral fractures.
"We are very excited to introduce our new Proximal Humeral Fracture Plate System. Not only does the system expand our shoulder product family, but the plate design also has some unique advantages, including a four screw hole option for calcar screws that allows for solid fixation in the calcar neck and provides humeral head support," said Bill Weber, Integra's Vice President and General Manager, Extremity Reconstruction.
The Integra Proximal Humeral Fracture Plate System offers two plate designs to address varying degrees of complex proximal humeral fractures. The two designs include a GT Plate and LP Plate in multiple anatomic left and right plate options. Both plate designs allow for varying screw diameters and lengths in locking, non-locking and lag screws options.
Approximately 108,000 shoulder fixation procedures will be performed on patients 65 years and older in the United States this year. A proximal humeral fracture is the third most common fracture reported in emergency rooms. Over 50% of all humeral fractures that are surgically treated are corrected using humeral plating systems.
Integra's Proximal Humeral Fracture Plate System will be available at Integra's booth (3465) at the 2013 AAOS Annual Meeting in Chicago, Illinois, March 20-22, 2013. Integra will also offer live demonstrations and opportunities for hands-on experience of its products.
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.
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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, 2012 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: United States
Integra LifeSciences Holdings Corporation
Gianna Sabella
Director, Corporate Communications
(609) 936-2389
gianna.sabella@integralife.com