TUCSON, Ariz. — The Freedom portable driver received FDA approval on June 26, 2014 for use with the SynCardia temporary Total Artificial Heart as a bridge to transplantation in cardiac transplant candidates who are clinically stable.
"With the FDA approval letter for the Freedom portable driver, SynCardia Certified Centers may now use the Freedom portable driver with all of their clinically stable patients," Michael Garippa, SynCardia’s CEO and President, said in making the announcement today. "These patients can be discharged and live in their homes and communities while they wait for their matching donor hearts. We anticipate that this will save patients, hospitals and insurance companies thousands of dollars through eliminating most in-hospital costs for this portion of patient care."
The FDA Premarket Approval Study (PMA) of the Freedom driver excluded patients needing IV therapy or outpatient dialysis, Garippa explained. With the FDA approval of the Freedom PMA study, stable patients who need IV therapy and/or outpatient dialysis will now be able to be discharged from the hospital with the Freedom driver and take care of those conditions as needed as a walk-in patient.
The PMA involved 22 SynCardia Certified Centers in the U.S. that provided the Freedom driver to 96 SynCardia Total Artificial Heart patients. An additional 10 patients were given the Freedom under compassionate-use exemptions at nine other SynCardia Certified Centers.
Those 106 patients received 58 total years of support starting when they were first switched to the Freedom portable driver in the U.S. study. The SynCardia Total Artificial Heart with the Freedom Drive System allowed 75% of those patients to be discharged from the hospital, while 86% of the 106 patients either were bridged to heart transplants or were alive and supported by the SynCardia Total Artificial Heart and the Freedom driver as of June 30, 2014.
"Most Freedom patients are free to exercise, eat out at restaurants, sleep in their own beds and socialize, all of which help contribute to better outcomes for these patients’ human heart transplants," Garippa said.
How the Freedom Portable Driver Works
The 13.5-pound Freedom driver can be carried in a backpack, shoulder bag, walker or a rolling caddy. It powers the Total Artificial Heart with precisely calibrated pulses of air and a small amount of vacuum so that the diaphragm is in the proper position to accept the next filling of blood into each artificial ventricle.
Like a heart transplant, the SynCardia Total Artificial Heart is designed to eliminate the source of end-stage biventricular failure by replacing both failing ventricles and the four heart valves of a patient.
The Freedom runs on lithium-ion batteries that are re-charged using a standard electrical outlet or a car charger which can be used in autos and many boats.
The Freedom was approved in Europe when it earned the CE Mark in March 2010. It received approval for use by Health Canada May 25, 2011.
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,300 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.
SynCardia Systems also manufactures the Freedom portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 175 patients, accounting for over 100 years of support.
Press release via SynCardia.