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.
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held 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 heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,250 implants of the Total Artificial Heart, accounting for more than 350 patient years of life on the device.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 97 SynCardia Certified Centers worldwide with 39 others in the process of certification.
The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.