fda unmet needs exemption

Long time ago, SHC applied and was knocked back on a special exemption on the grounds it met a need not covered in the system. FRom memory what I was told it was knocked back because best medical was seen as existing and adequate. Cost was also a question on an overburdened system.
If the trial results keep rolling along and improving like the last 6 months it would seem hard for this to stand.
27% 1 yr survival rate for Best Medical would not seem adequate.
C-Pulse is also demonstrating cost effectiveness.

As an aside this is a presentation that puts the best foot forward for VADs.
Note how VADs have improved over time the same could be expected for C-Pulse
Hard to compare data VADS Probs being in blood stream remain. Hidden a bit I feel in this presentation.
C_Pulse no strokes etc

http://www.vadparadigm.com/Are VADs ready to be mainstream?
Joseph G. Rogers, MD