Thursday, June 13, 2013

BRIEF-FDA staff does not recommend approval of Abbott's MitraClip

March 18 (Reuters) - Abbott Laboratories :

* FDA staff says approval of Abbott's MitraClip not appropriate at the

time as major questions of safety, efficacy & risks remain unanswered

* FDA staff recommends Abbott's MitraClip to remain available for high risk

patients so Abbott can conduct its trials in an optimal manner

* FDA staff says the analyses included in Abbott's MitraClip marketing

application do not have valid scientific evidence of safety & efficacy

* Source text * Further company coverage ((Bangalore Newsroom; +1 646 223 8780))


View the original article here

0 comments:

Post a Comment