Healthcare Industry News: Zimmer
News Release - July 6, 2006
Zimmer Holdings Receives U.S. Regulatory Approval to Begin Sale of Ceramic Hip ReplacementsMetal-on-Metal Offering Launched in June
WARSAW, Ind., July 6 (HSMN NewsFeed) -- Zimmer Holdings, Inc. (NYSE: ZMH ; SWX: ZMH ), a leader in the orthopaedics industry, announced today that it has received approval of its Premarket Approval Application (PMA) from the United States Food and Drug Administration (FDA) to market the Trilogy AB® Ceramic-on-Ceramic Acetabular System. In November 2005, the FDA issued an approvable letter indicating that the PMA was approvable subject to FDA inspection of the Company's facilities related to the Trilogy AB System.
This approval, along with the launch in June of the Durom® Acetabular Component for metal-on-metal articulation with Metasul® LDH(TM) Large Diameter Femoral Heads, greatly expands Zimmer's ability to offer alternate bearing options for hip replacement. The Durom/Metasul Large Diameter Head couple is designed to restore patient function by providing natural joint restoration, maximizing range of motion and reducing the potential for post- operative dislocation.
"We are very pleased to now be able to offer a ceramic-on-ceramic acetabular option to our customers in the United States," said Ray Elliott, Zimmer Holdings Chairman, President and CEO. "We have been anticipating this letter and are preparing to launch the product in the next two weeks, filling an important opening in our U.S. hip product portfolio. We will now be able to address our customers' needs for a wide spectrum of bearing surfaces, from our industry-leading Longevity® Highly Crosslinked polyethylene, to our new Durom/Metasul LDH metal-on-metal option and, now, Trilogy AB ceramic-on- ceramic."
The Trilogy AB System is part of the Trilogy® Acetabular System, which was initially launched in 1994 and evolved from the successful Harris/Galante and HGP II Acetabular Cup System designs. According to Zimmer, the Trilogy Acetabular System is the world's largest selling family of acetabular products. The Company said 2005 revenue for Trilogy Acetabular Shells and associated liners was approximately $150 million.
The Company's Metasul bearing technology was first introduced in 1988 and, unlike competitive offerings, is a forged, high carbon cobalt-chromium alloy product. These characteristics have established the technology as the industry standard for strength and low metal-on-metal wear.
The Trilogy AB femoral head and insert components are made of alumina ceramic and are designed to provide hard, wear-resistant articulating surfaces. Zimmer originally submitted its request for approval to market the Trilogy AB products in December 2004. The product has been sold outside the U.S. since 2001.
About the Company
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer is the worldwide #1 pure-play orthopaedic leader in designing, developing, manufacturing and marketing reconstructive and spinal implants, trauma and related orthopaedic surgical products. Zimmer has operations in more than 24 countries around the world and sells products in more than 100 countries. Zimmer's 2005 sales were approximately $3.3 billion. The Company is supported by the efforts of more than 6,700 employees worldwide.
Visit Zimmer on the worldwide web at http://www.Zimmer.com
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. These risks and uncertainties include, but are not limited to, our ability to successfully integrate Centerpulse AG and Implex Corp., the outcome of the Department of Justice investigations announced in March 2005 and June 2006, price and product competition, rapid technological development, demographic changes, dependence on new product development, the mix of our products and services, supply and prices of raw materials and products, customer demand for our products and services, control of costs and expenses, our ability to form and implement alliances, international growth, governmental laws and regulations affecting our U.S. and international businesses, including tax obligations and risks, product liability and intellectual property litigation losses, reimbursement levels from third-party payors, general industry and market conditions and growth rates and general domestic and international economic conditions including interest rate and currency exchange rate fluctuations. For a further list and description of such risks and uncertainties, see the disclosure materials filed by Zimmer with the U.S. Securities and Exchange Commission. Zimmer disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 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.
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