Healthcare Industry News:  total knee 

Devices Orthopaedic FDA

 News Release - August 24, 2007

Smith & Nephew Wins Gender Knee System Clearance

Nation's first "total" knee system cleared for gender specificity

MEMPHIS, Tenn.--(HSMN NewsFeed)--Smith & Nephew, Inc.'s (NYSE: SNN ; LSE: SN ) Orthopaedic Reconstruction business today announced FDA clearance for Smith & Nephew's JOURNEY(TM) Bi-Cruciate Stabilized (BCS) Knee System, the GENESIS(TM) II total knee System and the LEGION(TM) Revision Knee System product lines for gender specificity product requirements. This gives Smith & Nephew the largest breadth of knee products cleared for gender specific attributes, affirming the company as market leader with a range of customized products to meet changing needs of active, informed patients.

Unlike competitive knee systems being marketed as gender specific, Smith & Nephew offers the only anatomic tibial baseplate for both the right and left knees. The asymmetric design of the tibial baseplates used in the Smith & Nephew system ensures an anatomically accurate fit of the tibial baseplate component to the proximal tibia for male and female components. In order to substantiate said claims, Smith & Nephew analyzed the gender and sizing distribution of over 1,300 GENESIS II implants, reviewed over 300 CT scans, and analyzed 200 knee replacement procedures.

"Smith & Nephew knee products have long been solutions for active, informed patients," said Joseph DeVivo, president of Smith & Nephew Orthopaedic Reconstruction. "This recent FDA clearance demonstrates that our knee reconstruction product line offers a breadth of individualized implant solutions designed to treat patients suffering from knee osteoarthritis that provide both the fit and function necessary to regain an active lifestyle. Our mission is to meet needs of all individuals and provide the best possible products for both men and women who want more than ever to regain their passion for life."

Dr. Steven B. Haas, Chief of the Knee Service at Hospital for Special Surgery in New York, explained: "With this clearance, doctors and patients are now afforded choices to make more informed decisions and ensure the optimal outcome."

This confirms the size and shape of the GENESIS II Knee System has incorporated unique features of both men and women since its introduction in 1996. With over 500,000 implanted worldwide, the GENESIS II Knee System has the longest clinical follow up of any knee cleared for gender specificity. The JOURNEY Bi-Cruciate Stabilized Knee System, Smith & Nephew's most recently introduced total knee product, was developed using over 50 design iterations in order to optimize the shape and fit of the component. The unique design features of the JOURNEY Knee System provide function for both the anterior cruciate ligament (ACL) and the posterior cruciate ligament (PCL) and result in improved stability and motion in both males and females. The LEGION Revision Knee System meets the unique demands of revision surgery and is the only dedicated revision component for gender specific attributes.

These systems feature Smith & Nephew's proprietary OXINIUM(TM) technology, a superior metal for use in production of knee and hip implants. This advanced material exhibits exceptional performance due to hardness, low-friction and resistance to roughening and abrasion. With its negligible nickel content, OXINIUM Oxidized Zirconium has been found to be more hypoallergenic than previously available materials in hip and knee replacements.

(TM) Trademark of Smith & Nephew. Reg. US Pat. & TM Off.

About OXINIUM Oxidized Zirconium

OXINIUM material is a unique and advanced bearing product technology created through a proprietary manufacturing process that transforms the surface to a ceramic, resulting in a material that incorporates the best features of ceramic and metal while avoiding the limitations associated with either material. OXINIUM material is a revolutionary technology used in the production of components of knee and hip implants that exhibits superior performance characteristics due to its hardness, low-friction and resistance to roughening and abrasion.

The concept of using oxidized zirconium as a joint replacement material was developed by the many individuals within Smith & Nephew Orthopaedic's Research, Development, and Manufacturing groups. OXINIUM technology has been modeled on the highly successful GENESIS II knee system, which itself has been utilized in excess of 500,000 surgeries worldwide. The first oxidized zirconium component was implanted in 1995. Since then, over 100,000 hip and knee components have been implanted with remarkable success.

About us

Smith & Nephew is a global medical technology business, specializing in Orthopaedic Reconstruction, Orthopaedic Trauma & Advanced Wound Management products. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.

Smith & Nephew is dedicated to helping improve people's lives. The Clinical Therapies, Endoscopy and Company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust. The company has 9,600 employees and operates in 31 countries around the world generating annual sales of nearly $2.8 billion.

Forward-Looking Statements

This press release contains certain "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995. In particular, statements regarding planned growth in our business and in our trading margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors.

All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.


Source: Smith & Nephew

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