By Alan Fischer
TNAZ Senior Writer
SynCardia's Freedom discharge driver, left, will allow patients using the firm's Total Artificial Heart, right, to live normal lives at home as they await a human donor heart transplant.
Credit: SynCardia Systems Inc.
An Arizona company is working to offer the freedom of mobility to patients awaiting a human donor heart.
SynCardia Systems Inc.'s CardioWest Total Artificial Heart has been implanted as a bridge-to-transplant device in more than 800 people awaiting a human heart, said Rodger G. Ford, the firm's president and CEO.
The pneumatic Total Artificial Heart, which replaces both heart ventricles in the patient, requires a driver device for power to keep blood pumping though the body.
Currently Total Artificial Heart patients must be tethered to a cabinet-sized 450-pound "Big Blue" driver that keeps them in the hospital for weeks, or even months, as they await an available transplant heart.
Tucson-based SynCardia has developed and is now testing a portable driver called the Freedom that will allow patients to leave the hospital and resume their normal lives during the waiting period for a heart.
The Total Artificial Heart is approved by the FDA and the company is working to secure FDA approval for the Freedom discharge driver, Ford said.
Freedom, weighing 12-pounds, can be carried in a backpack or shoulder bag.
The Freedom driver allows patients to leave the hospital as soon as they are medically stable following the replacement of their ventricles with the Total Artificial Heart. This typically only takes a few days, Ford said.
The body reacts quickly to the improvement from improved cardiovascular circulation due to the artificial heart taking over for the diseased organ.
"When we get them they are ready to die," Ford said. Following the installation of the Total Artificial Heart, he said, "They wake up and say, 'I haven't been this pink in a long time.' And they are out of bed in two or three days, they are ambulating, and they get better."
The Freedom driver will allow patients to return home where they want to be, enjoying a normal lifestyle and not tethered to a hospital bed. People can carry the portable 12-pound driver as they shop, drive, do chores and even exercise, Ford said.
The Freedom drivers are not for sale. When a person purchases the Total Artificial Heart for $124,700 they get the use of two Freedom drivers – one for a backup – to keep the temporary heart pumping while they await a human donor heart.
Patients are taught to switch from one driver to another is an alarm goes off showing there is a problem.
"You've got about 45 seconds to do it before you black out," Ford said. "We train them to do that. It scares them, so we do it over and over again until they are over the fear."
The drivers feature numerous redundancies, including backup batteries, gearboxes and motors, to ensure they continue operating.
With people's lives depending on the Freedom driver, exhaustive testing is used to prove reliability of the components as well as complete units.
"Its' got to be perfect. Everyone has to make it perfect. And it's got to be perfect independently and perfect when you put it together.
A SynCardia test lab hums with the sound of Total Artificial Hearts powered by Freedom drivers pumping six liter of liquid per minute.
Components like the yolk that pumps air through the device's pneumatic cylinder to push blood through the artificial heart are tested to failure. Complete Freedom units are tested for reliability, and to determine how often servicing will be required.
The Freedom drivers are also subjected to drop testing, and to ensure they operate at 10,000 feet in elevation for people on the discharge driver who fly.
The company plans an initial production run of 500 Freedom drivers, which will accommodate 250 patients using the Total Artificial Heart while awaiting donor hearts, Ford said.
About 300,000 people die of heart failure each year, Ford said. For those dying from end=stage biventricular failure, there are two options for survival: the immediate transplant of a human donor heart or the Total Artificial Heart as a bridge to transplant, he said.
Because only about 2,200 human transplant hearts are available in the United States Each year, the Total Artificial Heart is an option needed to save lives. Ford said about 12,500 patients per year could benefit by using the Total Artificial Heart, which could mean $1.5 billion in business for SynCardia in the United States alone.
The company plans to seek FDA approval to use the Total Artificial Heart as a permanent device by people who are not eligible to receive a human donor heart.
"It could be used forever. They would not be a bridge-to-transplant candidate, they would be a destination candidate," Ford said.