[HSF] FDA

[Ani Anyanwu]

Hal I was thinking exactly the same thing - even the poor folks in Europe will now be saved from the scourge of Mitrofast.

Does anyone know though what exactly was the problem with Shelhigh that prompted FDA to take such drastic measures? The FDA release suggests problem with both durability and sterility of their products. I must say I find the durability aspect interesting as I recall meeting some senior people from Shelhigh 18 months ago who professed that their 'No-react' range was totally immune from calcification.

Also interesting is that the FDA seemingly knew these problems at least 6 months ago but only acted now.

Ani
  ----- Original Message ----- 
  From: Hgrmd at aol.com<mailto:Hgrmd at aol.com> 
  To: OpenHeart-L at lists.hsforum.com<mailto:OpenHeart-L at lists.hsforum.com> 
  Sent: Thursday, April 19, 2007 8:53 PM
  Subject: Re: [HSF] FDA


  Dear Ben,
    I guess that's the end of the Mitrofast debate for at least the  
  intermediate future.
  Hal



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