Allison - I assume you may already be in surgery by now, so first things first...wishing you all the best and hope to hear soon of a smooth and steady recovery!
I couldn't agree more about the poor timing of this "option" and sure hope that it hasn't had any impact on your pre-surgery resolve. I was not familiar with this Edwards product/technique until your post, but did some brief research, and it appears that the valve and delivery system is already approved in Europe (CE Mark - February 2012), which seems to happen fairly often...FDA approvals lag a year or two behind. There was a trial for approval in Europe (TRITON) also so I would assume the surgeon is aware of the results and wouldn't be suggesting it unless he was both knowledgeable and also pretty confident in the results. I believe the valve may also include a new tissue treatment process (GLX).
So, either way, I hope that may be slightly more reassuring. Although, in my opinion, all of the data in the world (which this most certainly is not, this is still very limited) can only be so effective if patients aren't even given adequate time to review it! Plus, I think there is generally a reason FDA approval takes longer...it potentially may be more thorough and require a higher degree of certainty of outcomes (additional trial evidence in some cases). The FDA does actually publish a lot of their internal review materials, which point out any limitations in the available evidence, but I haven't been able to find any, and it may not even exist yet, since this is still only a trial here in the US.
Anyway, this was not at all a thorough research project, nor even the best sources, but in the short time I had, here a few articles I found with a little more info than you may already seen:
http://www.dicardiology.com/article/edwards-intuity-valve-receives-ce-mark
http://www.dicardiology.com/article/new-data-edwards-intuity-valve-demonstrate-promise-rapid-deployment-platform
http://www.edwards.com/newsroom/Pages/NR20120608.aspx
