Guest guest Posted April 21, 2004 Report Share Posted April 21, 2004 > > So why don't we call start calling and emailing the FDA to approve > > Hip Resurfacing? I see that its been on the books of the FDA since > > 1976. What is taking so long to get approved. > > I would NOT recommend this. Devices are approved based on scientific > evidence and not on public opinion or lobbying. There is currently > an application for marketing submitted for the Conserve Plus ( > Medical) which includes two-year follow-up data from the clinical > trial of that device. There should be a ruling on it later this > year, perhaps as soon as June. > > Corin is continuing their clinical trial (Cormet device) and will > submit data from it to get marketing approval for their device. Off > the top of my head I don't recall their specific timeline. Probably > within the next two years. > > +Nephew recently bought Midland Medical Technologies and > expressed the desire to seek approval for marketing the BHR in the US. This is probably a dumb question, but are there other reasons for FDA approval besides health insurance coverage? It seems that a lot of the people gettting the Conserve Plus device are saying that their health insurance paid for it. Am I wrong? I am starting to understand that even though something is not FDA approved that there seems to be ways to get around it to have the resurfacing done. Does anyone know how these devices compare to one another? I have only heard of the BHR, Conserve Plus and Cormet. Quote Link to comment Share on other sites More sharing options...
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