WARSAW, Ind., Dec. 11 /PRNewswire-FirstCall/ -- Zimmer Holdings, Inc. , a leader in the orthopaedics industry, announced today that its Premarket Approval (PMA) application for the Zimmer(R) NexGen(R) LPS-Flex Mobile Knee has been granted by the Food and Drug Administration.
“A number of orthopaedic surgeons prefer mobile bearing designs and we are pleased to be one of only two companies that can offer this treatment option in the U.S.,” said Sheryl Conley, Zimmer Chief Marketing Officer. “Since its launch in Europe in 1999, this product has been well received in Australia and Japan, as well as in Europe. We look forward to being able to provide the mobile bearing option to surgeons here in the United States where the majority of the world’s knee replacement procedures are performed.”
Zimmer says that a key strength of its mobile bearing system is its ability to be used in a minimally invasive procedure -- the LPS-Flex Mobile Knee is compatible with the Company’s industry leading Minimally Invasive Solutions(TM) (MIS(TM)) Systems and Technologies knee replacement instrumentation.
The main difference between a traditional knee replacement design and a mobile bearing knee is that the polyethylene articulating surface is free to rotate slightly along with the patient’s natural movement. When used with the LPS-Flex femoral component, the knee replacement is designed to safely accommodate active deep flexion of up to 155 degrees for patients who are otherwise capable of that level of flexion. Many activities of daily living require this range of motion, such as climbing stairs (75-140 degrees), sitting in a chair and standing up again (90-130 degrees), and squatting (130-150 degrees). Generally, knee implants were designed to accommodate flexion of only 120 degrees.
Zimmer is the world leader in knee replacement product sales. The NexGen(R) Complete Knee Solution, its flagship brand, includes a wide range of designs to accommodate various surgical philosophies and patient requirements.
The Company says that it expects to begin the limited release of the LPS-Flex Mobile knee in January and expects general availability in the U.S. in mid-2008.
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 2006 sales were approximately $3.5 billion. The Company is supported by the efforts of more than 7,000 employees worldwide.
Visit Zimmer on the worldwide web at 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 acquired businesses, the impact of our settlement of the federal investigation into financial relationships with consulting surgeons, including our compliance with the Deferred Prosecution Agreement through March 2009 and the Corporate Integrity Agreement through 2012, the outcome of the Department of Justice Antitrust Division investigation announced in June 2006, the outcome of the informal investigation by the U.S. Securities and Exchange Commission into Foreign Corrupt Practices Act matters announced in October 2007, 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 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.
CONTACT: Media, Brad Bishop, +1-574-372-4291, bradley.bishop@zimmer.com;
Investors, Sean O’Hara, +1-574-371-8032, sean.f.ohara@zimmer.com, or James
T. Crines, +1-574-372-4264, james.crines@zimmer.com, all of Zimmer
Holdings, Inc.
Web site: http://www.zimmer.com//
