ynCardia Introduces New 12-lb Freedom™ Discharge Driver. Designed to Provide Quality “Lifestyle” for Total Artificial Heart Patients. The 12-lb Freedom driver is designed to provide stable Artificial Heart patients with a quality “lifestyle” outside the hospital while they wait for a matching donor heart. SynCardia Systems, Inc. is the 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) 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. 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.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary Total Artificial Heart. There have been more than 850 implants of the Total Artificial Heart, accounting for more than 190 patient years of life on the device. Originally used 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 Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.You can see on the Youtube video below how it works this device. For additional information just visit:
www.syncardia.com
www.youtube.com/watch?v=Gv9xB9HQsww&feature=player_embedded
