Interesting to see if they are repositioning C-Pulse. Pretty...

Interesting to see if they are repositioning C-Pulse. Pretty obvious they had been forced into implanting patients far sicker than the device had been intended for. Guessing the FDA is "forcing" ssh to implant less sick patients then this must slow enrolment. (Probably wouldn't change the underlying efficacy? just make a "cleaner" trial.) Assuming the move is supported by practitioners, i.e., selection committee, the support by the FDA and Doctors for implanting a better defined less sick population is a great endorsement for C-Pulse and Rosa, and should greatly increase the rate of enrolment over the medium term.