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[December 2003]
FDA Approves Ceramic-on-Ceramic Hip Implant
Encore Medical Corporation (Austin, TX, USA) announced on 1 December 2003 that it had received pre-market approval from the US Food & Drug Administration (FDA) for its Keramos (tm) ceramic-on-ceramic acetabular hip replacement. This new system is said to offer younger and more active patients an alternative for improving the long-term performance of artificial hip replacements.
Using an alumina ceramic material, the Encore system combines superior material strength and low wear characteristics to meet the demands of the most active patients and to reduce the frequency of revision surgery. The company said that traditional materials of polyethylene and metal had been shown to wear over time and thus cause, in many cases, the need for revision surgery in young and active patients.
Jack Cahill, President of Encore's Surgical Division, said: "This is a technology that is based on material that has shown greater potential to increase the long-term success of hip prostheses. From a product-offering standpoint, we are particularly excited because with this FDA approval, Encore now offers as broad an array of acetabular hip product options as any company in the United States. In addition, we anticipate our Keramos ceramic-on-ceramic hip will carry a price premium to the current high-end hips available".
ENDS