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[July 2006]
Zimmer Receives US Regulatory Approval to Begin Sale of Ceramic Hip Replacements
Zimmer Holdings Inc (Warsaw, IN, USA), a leader in the orthopaedics industry, announced on 6 July 2006 that it had 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™ 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, maximising 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 US$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, added Zimmer.
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 USA since 2001.
www.zimmer.com
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