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Post# of 108192
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khaled_shatila

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khaled_shatila

Re: hovacre post# 49941

Friday, 01/19/2018 10:12:52 AM

Friday, January 19, 2018 10:12:52 AM

Post# of 108192
not in my experience, here are some examples:

"In Europe:
HeartMate II : BTT and DT in November 2005
HeartWare : BTT in 2009 and DT in 2012.

In the USA:
HeartMate II : BTT since 2008 and as a DT since 2010
HeartWare : BTT since 2010 and for DT in 2017"

I have other examples as well
but again i might be talking about a narrow field but the broader trend is what you mentioned (which i doubt otherwise the FDA wouldn't feel so compelled to release this change in direction for approvals)
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