An FDA PMA Decision May Be Pushed Back Into 2020 As Window Of Opportunity Closes
1- A slow enrollment already is pushing back the enrollment-completion-date.
2- In EARLY 2014 the HeartMate III starts clinical trials with a design that should sharply lower surgery-time, ICU stay and Hospital stay. It should ELIMINATE the CPB, also sharply reduce or eliminate the Von Willebrand disease and bleeding. And MOST IMPORTANT, unlike the LOW EF of many patients using the C-Pulse, bring 100% of the HeartMate III device a BLOOD FLOW that nourishes ALL the organs to the LEVEL THEY need. This could provide HeartMate III patients with TWENTY YEARS or more of LIFE. Remember that Heartmate II patients are nearing NINE YEARS now and still COUNTING. The HeartMate III is an order of magnitude better.
3- I STRONGLY THINK the HeartMate III's clinical trial will INCLUDE late stage CLASS III patients.
4- By NOT being able to meaningfully enroll patients in the COUNTER HF trial, SSH missed a HUGE opportunity which will, IN MY OPINION, cause a very large DELAY for a PMA decision.
Bigs spreading lies again. Do your cats speak to you and reveal this all telling information? The SSH study just started. SSH will have 11-19 sites set up by end of Dec. They'll have 35 sites set up around end of 1st to 2nd quarter. They just posted a new Powerpoint on their website stating the enrollment will be completed 2015. They'll be able to make up any lost ground on enrolling patients once all the sites are set up. I'll finish with you never learn or listen. Heartmate has to redesign, retest and resubmit to the FDA for the plan design change to the pump. If you think that will be done in only a couple of months you really are not the sharpest knife in the draw. I guarantee you Heartmate will be lucky to start testing by the End of 2014. They might not even start until 2015. Please share this with the cats and let us all know what they say.
Yes he is nuttier than squirrel turds. WITH posts that USE UPPERCASE as he THINKS it PROVES his POINT and make HIM more BELIEVABLE. It is obvious he has some kind of mental disorder and I am honestly not saying that to be mean or make him mad. He obviously has something going on which his making him so unstable. I have never seen anyone like it and yes 11 cats says a lot.
1- Furthermore, I see some posts declaring the C-Pulse as the GOLD STANDARD without explaining why.
2- Furthermore, I see some Seeking Alpha authors claiming that patients will choose the C-Pulse over the HeartMate II. So my question is what about the HeartMate III?
3- If I had a LOW EF and saw to date, that no C-Pulse patient reached an EF equilibrium of greater than 50%, and MOST were well UNDER 50%, and I saw that Heartmate III patients could receive a blood flow up to TEN LITERS PER MINUTE where FIVE LITERS PER MINUTE is required for someone at REST, I would DEFINITELY go with the HeartMate III, especially after reading about the great improvements of the HeartMate III over the HeartMate II. Then when I was given FACTS about survivability of HeartMate II patients approaching NINE YEARS and counting, that would be a SLAM DUNK for the HeartMate III.
4- Yes folks, the EF is still an important metric. Having an EF of 20% would definitely concern me.