Guest guest Posted March 15, 2004 Report Share Posted March 15, 2004 > http://www.smith-nephew.com/news/item.jsp?id=203 Thanks Jim, thats great news. Investing $150,000,000 in resurfacing is a great signal that it will be the wave of the future. Money talks and bs walks! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 17, 2004 Report Share Posted March 17, 2004 Rog: I agree!. I pointed this out several months ago in a number of posts. They will wait until Corin or get approval from the FDA. Then they can apply for approval " as safe and effective as the predicate device " . Thus they will avoid the expense and delay of a clinical trial. By the way, we seem to be getting closer to approval. Maybe by the end of the summer. Next meeting for orthopedic devices is not until June. No way to know without official announcement by the FDA. The manufacturers are prohibited from any premature announcement. (MD in NC). (L) C+, 3/31/03 Dr. Vail > One point of interest especially for those US citizens that appears > important is covered by the the following part of the press release > > " The BHR procedure has been used in over 27,000 patients since 1997 > and has significant clinical experience, particularly in the UK, > Germany and Australia. & Nephew intends to pursue Food and > Drug Administration approval of the product in the United States. " > > Those who are going the Belgium route will have cover back home. > > Rog BHR both hips 2001 Mr Treacy > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 17, 2004 Report Share Posted March 17, 2004 Rog: I agree!. I pointed this out several months ago in a number of posts. They will wait until Corin or get approval from the FDA. Then they can apply for approval " as safe and effective as the predicate device " . Thus they will avoid the expense and delay of a clinical trial. By the way, we seem to be getting closer to approval. Maybe by the end of the summer. Next meeting for orthopedic devices is not until June. No way to know without official announcement by the FDA. The manufacturers are prohibited from any premature announcement. (MD in NC). (L) C+, 3/31/03 Dr. Vail > One point of interest especially for those US citizens that appears > important is covered by the the following part of the press release > > " The BHR procedure has been used in over 27,000 patients since 1997 > and has significant clinical experience, particularly in the UK, > Germany and Australia. & Nephew intends to pursue Food and > Drug Administration approval of the product in the United States. " > > Those who are going the Belgium route will have cover back home. > > Rog BHR both hips 2001 Mr Treacy > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 17, 2004 Report Share Posted March 17, 2004 Rog: I agree!. I pointed this out several months ago in a number of posts. They will wait until Corin or get approval from the FDA. Then they can apply for approval " as safe and effective as the predicate device " . Thus they will avoid the expense and delay of a clinical trial. By the way, we seem to be getting closer to approval. Maybe by the end of the summer. Next meeting for orthopedic devices is not until June. No way to know without official announcement by the FDA. The manufacturers are prohibited from any premature announcement. (MD in NC). (L) C+, 3/31/03 Dr. Vail > One point of interest especially for those US citizens that appears > important is covered by the the following part of the press release > > " The BHR procedure has been used in over 27,000 patients since 1997 > and has significant clinical experience, particularly in the UK, > Germany and Australia. & Nephew intends to pursue Food and > Drug Administration approval of the product in the United States. " > > Those who are going the Belgium route will have cover back home. > > Rog BHR both hips 2001 Mr Treacy > > Quote Link to comment Share on other sites More sharing options...
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