World’s 1st Total Artificial Heart Patients Discharged Home
Using SynCardia’s Freedom® Portable Driver
U.S. Patient Marks 50 Days of Freedom Driver Support at Home as 1st Participant in FDA Clinical Study
TUCSON, Ariz. – June 22, 2010 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that the world’s first three Total Artificial Heart patients have been discharged from SynCardia Certified Centers using the new Freedom® portable driver. Weighing 13.5 lbs, the Freedom driver is the world’s first wearable portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital.
1st European Patient - Nantes, France
- University Hospital of Nantes switched Europe’s first Total Artificial Heart patient to a Freedom driver on May 21, and discharged 36-year-old Eric Quantin on May 28. “He really appreciated the increased mobility that the Freedom driver gave him and was very happy to be at home,” said Prof. Daniel Duveau, Medical Director of the Thorax Institute at University Hospital of Nantes. “The patient received a matching donor heart three days later and is in good condition.”
World’s 1st Female Patient - Moscow, Russia
- The Bakoulev Scientific Center for Cardiovascular Surgery placed the first female Total Artificial Heart patient on a Freedom driver on May 21 and discharged her home on June 4. Tatyana, 60, was the world’s 850th recipient of the Total Artificial Heart. Using the Freedom portable driver, Tatyana was able to visit with her first grandson, who was born just days after she received the Total Artificial Heart.
1st U.S. Participant in IDE Clinical Study - Phoenix, Arizona
- On May 3, a Phoenix-area SynCardia Certified Center discharged the first U.S. Total Artificial Heart patient as part of the FDA Investigational Device Exemption (IDE) clinical study of the Freedom driver. Charles Okeke, a 43-year-old father of three, surpassed 50 days of support with the Freedom driver at home on June 22. The IDE clinical study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be used safely at home.
The Freedom driver has the CE Mark for use in Europe and has received conditional approval from the FDA to undergo an IDE clinical study in the U.S.
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.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved 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 1,350 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.
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 190 patients, accounting for over 110 years of support.