Tucson, Ariz. (Vocus) April 22, 2009
On April 22-25, SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, introduced the new 12-lb Freedom™ discharge driver at the International Society for Heart and Lung Transplantation (ISHLT) meeting in Paris.
The small, light and “wearable” Freedom driver is designed to provide stable SynCardia Total Artificial Heart patients with a quality “lifestyle” outside the hospital while they wait for a matching donor heart. The Freedom driver is designed to allow patients to live at home, spend time with their family and friends, shop, travel, dine out, attend sporting events, vacation and even return to work.
“The Freedom driver is the next generation in pneumatic driver technology for powering the Total Artificial Heart outside the hospital,” said Rodger Ford, CEO and president of SynCardia. “Our experience discharging stable patients in Europe using our CE approved portable driver has demonstrated that Total Artificial Heart patients can enjoy an active lifestyle at home and in their communities.”
Currently in the U.S., stable Total Artificial Heart patients cannot be discharged. These patients – who are otherwise healthy – must spend weeks, often months trapped in the hospital while they wait for a donor heart. Life for a stable Total Artificial Heart patient confined to the hospital is emotionally, physically and financially draining for them, their family and the hospital.
When the Freedom driver is approved for an FDA / Investigational Device Exemption (IDE) clinical study, stable Total Artificial Heart patients will be discharged from the hospital for the first time in the U.S. Discharge improves quality of life while eliminating most in-hospital costs for this portion of their care.
In Q2 2009, SynCardia plans to submit applications for CE approval of the Freedom driver in Europe and to the FDA to conduct an IDE clinical study of the Freedom driver in the U.S.
Caution– The Freedom™ driver is an investigational device, limited by United States and EU law to investigational use.
Originally designed as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end stage biventricular failure.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE approved Total Artificial Heart in the world. There have been more than 780 implants of the Total Artificial Heart, accounting for more than 150 patient years of life on the device.