Noone is facing up to the politics of this device.
WSJ today said the cost of this device is about $80,000 + HUNDREDS OF THOUSANDS MORE in attendant doctor and hospital fees. "Wide use of the pump could post new economic challenges for the healthcare system" continued the WSJ. A heart specialist at U of Penna said "There will be policy and finance implications. How will it be paid for...that will be interesting" This wonderful device flies in the face of everything Obamacare is trying to do--cut costs. On top of that Dr. Death--Ezekiel Emmanuel, Obama's Medical Advisor-- is an advocate of reducing spending on people whose most "productive years" are behind them...old people who are the most likely prospects. I wonder if political pressure from the top will pressure the FDA to drag their feet on approving expensive new medications and devices. P4... you are the expert on the medical aspects of THOR...but what about the politics?
This is expensive technology but there are also substantial costs involved in the maintenance of patients with CHF with drug therapy. I would also hope that as the market develops and more of these devices are produced and implanted that some of these costs would be mitigated. Regarding FDA approval timing, I am optimistic/hopeful that given the excellent results with HM2 vs. an approved XVE that approval for HM2 should occur soon.
The costs associated with late-stage CHF are huge.
As each organ starts a continuous dysfunction the cost of treating each dysfunction climbs exponentially. For example the costs associated with Kidney dysfunction, liver dysfunction, breathing dysfunction, treating depression, body wasting, severe pain and on and on. And all the time trips to the cardiologists and hospitalizations.
"The patients with heart failure (HF) often exhibit some degree of muscle wasting restricted to the lower limbs. This loss of tissue may become more extensive in some patients, usually when their HF is more advanced, and may affect all body compartments. The underlying metabolic causes are very complex and differ from patient to patient. Three essential contributors are dietary deficiency and loss of nutrients through the digestive tract and metabolic dysfunction. The development of cachexia is an ominous sign and new drugs will be added into our therapeutic armamentarium to fight against cardiac cachexia in the near-future."