I honestly thought Lonestar would have better results than this. I don't think their viable on these results( just my non medical non scientific etc. etc opinion)
Peak VO@
Very poor VO2 for a 60+ is < 20.51 http://www.machars.net/v02max.htm
Algisyl- LVR increase from 12.4 to 13.2 (still very poor)
We know marginal improvements can make significant improvements in a patients life (result is statistically significant), but as a PRIMARY END POINT, to me it appears very underwhelming.
6 Minute Walk
OK statistically significant.
NYHA
Over 6 months a general an improvement of 1 class, pretty good.
20% deteriorated HF in Control 10% in Implant. (Is that good enough?)
Adverse Events
Very significantly higher in Implant group
20% of patients in the Implant group had a major surgical complication.
(Would find it hard to believe that Algisyl- LVR is viable with this level of serious surgical complications)
Deaths.
This is one of the things that sunk Acorn, the device didn't improve survivability, may have even increased deaths.
5% target 8% actual, while within variability, doesn't dispel the cloud that Algisyl- LVR may adversely affect survivability.