RE: Re: & Nephew merge with MMT...........................

[Guest guest]

I listened to the conference call they did on the announcement of the

purchase. During the call they highlighted that point about the 27,000 BHR

case studies already in Europe and Australia. They said they had not yet

talked with the FDA but they seemed to be implying that the experience they

had would be strong evidence for the FDA. However, history with the ceramic

hips showed that this is not the case. It is the history of the FDA to

demand formal clinical studies in the US (I am not arguing that that is

entirely logical). They would be wise to learn from the ceramic experience

and not go to the FDA with a lot of hubris. The FDA in that case forced

changes in manufacturing and documentation which took awhile to implement

(that was of course also impacted by the " news of the day " at the time

regarding some of the ceramic-on-poly failures that were occuring due to

changes in manufacturing at another factory).

-

Re: & Nephew merge with

MMT...........................

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

>

>