Press Release:

SynCardia’s “Big Blue” hospital driver supports patients from implant of the Total Artificial Heart until their condition stabilizes. Through the IDE clinical study, stable Total Artificial Heart patients who meet study criteria will have the option to be discharged from the hospital with the Freedom™ driver system.

TUCSON, Ariz. – Mar. 29, 2010 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, today announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom™ driver system, the first-ever U.S. portable driver designed to power SynCardia's Total Artificial Heart. The SynCardia Freedom driver system IDE 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.

While the Total Artificial Heart has the highest bridge to transplant rate of all approved mechanical circulatory support devices, the major drawback of existing technology is that patients are confined to the hospital while they await a transplant. This is because the only FDA-approved driver for powering the Total Artificial Heart is the 418-lb hospital driver nicknamed “Big Blue”. Through the IDE, stable Total Artificial Heart patients who meet study criteria may have the option to be discharged from the hospital with the Freedom driver. The Freedom driver weighs only 13.5 lbs including two onboard lithium-ion batteries and a power adaptor. It is designed to be carried by the patient in the Freedom Backpack or Shoulder Bag.

Weighing 13.5 lbs including two onboard batteries, the new Freedom™ driver system is the first wearable portable driver designed to power SynCardia’s Total Artificial Heart.

“While waiting for a transplant, patients can stay in the hospital for several months and in some rare cases, more than a year,” said Dr. Stephen Clayson, associate surgical director of the Utah Artificial Heart Program at Intermountain Medical Center. “We are excited to participate in the IDE clinical study and evaluate the use of the Freedom driver to power the Total Artificial Heart. If the IDE clinical study of the Freedom driver is successful, patients will be able to sleep in their own bed, spend time with their families and be more self-sufficient.” 

The trial is expected to enroll 60 patients and will follow them until transplant, 90 days after discharge, 90 days of Freedom support in the hospital or death. Pending internal Institutional Review Board (IRB) approval, centers anticipated to participate in the study include Mayo Clinic Arizona, University Medical Center at the University of Arizona, Intermountain Medical Center and Virginia Commonwealth University Medical Center.

“I felt great with the Total Artificial Heart. I was able to exercise and improve my health while I waited to receive a transplant. However, it was extremely difficult being unable to leave the hospital for almost eleven months,” said Jim Hennigan, Total Artificial Heart patient and heart transplant recipient. “Had a portable driver been available, I would have been able to continue an active role in my children’s lives, including attending the father-daughter dance and their sporting events, and most importantly, saying good morning and goodnight in person everyday instead of over the phone.”

“The Freedom driver is the first wearable portable driver designed to power SynCardia’s Total Artificial Heart,” said Rodger Ford, president and CEO of SynCardia. “Stable Total Artificial Heart patients may have the opportunity to live outside the hospital while they wait for a matching donor heart. Life at home may potentially eliminate significant in-hospital costs for this portion of the patient’s care.”

The Freedom driver uses a “dark cockpit” design, meaning the driver only flashes a light and sounds an alarm when something requires the user’s attention. The Freedom driver is intended to be serviced by replacement via express delivery. No onsite repair or inventory of parts is required by the hospital.

On March 1, 2010, the Freedom driver received CE approval for use in Europe.

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About SynCardia Systems, Inc.

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 200 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.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660