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Home » Zimmer gets pediatric clearance for its scoliosis implant

Zimmer gets pediatric clearance for its scoliosis implant

September 16, 2011 By MassDevice Contributors Network

Fixation Implant System Now Indicated for Treatment of Scoliosis in Younger Patients

WARSAW, Ind., Sept. 14, 2011 /PRNewswire/ — Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH) announced today that it has received an additional clearance for its proprietary Universal Clamp Spinal Fixation System. A first for the United States, the system is now indicated for treatment of idiopathic and neuromuscular scoliosis in patients eight years of age or older. The Universal Clamp Spinal Fixation System is used in conjunction with spinal fusion surgeries.

Scoliosis is a debilitating condition characterized by spine curvature and back pain. In the United States, scoliosis affects approximately two to three percent of the population with more than 27,000 cases a year determined to be serious enough to require surgery. Scoliosis is commonly diagnosed in childhood and early adolescence, with between three and five of every 1,000 children developing spinal curves that are considered large enough for treatment. The most common surgical intervention performed to correct severe scoliosis is spinal fusion.

Zimmer’s Universal Clamp System was designed for use in conjunction with spinal deformity procedures. Introduced in Europe in 2006 and in the United States in 2008, the Universal Clamp Implant offers a pedicle-sparing approach for malformed or small thoracic pedicles while still providing similar stability to pedicle screw constructs. The Universal Clamp band spreads contact forces over a greater surface area, thereby reducing the risk of pulling through the lamina compared to wires and hooks. The system’s reduction instrumentation allows surgeons to sequentially reduce deformity and spread the reduction forces over multiple levels.

“Scoliosis affects a significant number of young patients in the United States each year,” said Steve Healy, President of Zimmer Spine. “We are excited to make the Universal Clamp System available as an advanced solution for surgeons treating young patients.”
Since its introduction, the Universal Clamp System has been successfully used in more than 24,000 procedures worldwide. Following the latest clearance, Zimmer can now provide training and education for surgeons to treat child and adolescent patients in the United States with the technology.
For more information on Zimmer Spine and the Universal Clamp Spinal Fixation System, visit www.zimmer.com.

About the Company
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer’s 2010 sales were approximately $4.2 billion. The Company is supported by the efforts of more than 8,000 employees worldwide.

Zimmer Safe Harbor Statement
This press release contains forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 based on current expectations, estimates, forecasts and projections about the orthopaedics industry, management’s beliefs and assumptions made by management. Forward-looking statements may be identified by the use of forward-looking terms such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” and “seeks” or the negative of such terms or other variations on such terms or comparable terminology. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that could cause actual outcomes and results to differ materially. For a list and description of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Readers of this document are cautioned not to place undue reliance on these forward-looking statements, since, while we believe the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this document.

SOURCE Zimmer Holdings, Inc.
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RELATED LINKS
http://www.zimmer.com

Filed Under: Uncategorized Tagged With: Regulatory Roundup, Zimmer Biomet

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