Hip Resurfacing :: FDA approves Cormet hip resurfacing products for US

Corin Group PLC confirms that at the FDA Advisory Panel Meeting, the Panel voted to recommend FDA approval with conditions of Corin?s hip resurfacing device, Cormet, for use in the USA.

The conditions recommended by the panel relate to a post market approval study, surgeon training and labelling. Corin looks forward to continued discussions with the FDA as part of the overall approval process.

Corin and Stryker, the Group?s exclusive US distribution partner, are aware that there is a substantial demand in the US from orthopaedic surgeons wishing to access this bone conserving hip resurfacing technology. With Stryker?s strong position in the US hip market, the Group will be well placed to target the rapidly emerging US demand for hip resurfacing, upon FDA approval.

Ian Paling, Chief Executive of Corin, commented

?To have secured the FDA Advisory panel recommendation is a critical step in the US approval process for Cormet. We pioneered metal on metal resurfacing technology in the late 1980?s and our Cormet device has been sold and successfully implanted around the world for almost a decade.

?We are now poised, subject to final FDA approval, to be able to supply the world?s largest orthopaedic market with our leading hip resurfacing product. We are very confident that the opportunities for Cormet in the US are substantial, as all our market research points to significant demand for this hip resurfacing technology, which is especially attractive to the younger, active ?baby-boomer? generation.?

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