Healthcare Industry News:  Artificial Heart 

Devices Cardiology Regulatory

 News Release - March 4, 2010

Freedom Driver System Receives CE Mark to Power SynCardia's Total Artificial Heart in Europe

1st Wearable Portable Driver Allows Stable European Patients to Enjoy Quality Lifestyle at Home While They Wait for a Matching Donor Heart

TUCSON, Ariz.--(HSMN NewsFeed)--On March 4, SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced that its new Freedom™ driver system has received the CE Mark to power the Total Artificial Heart in Europe.

“The new Freedom driver is the first wearable portable driver for powering the Total Artificial Heart,” said Rodger Ford, president and CEO of SynCardia. “It will allow stable European Total Artificial Heart patients to enjoy a quality lifestyle at home and in their communities while they wait for a matching donor heart.”

SynCardia hospital drivers support patients from Total Artificial Heart implant until their condition stabilizes. Once stable, European patients will be switched to the Freedom driver and discharged from the hospital to wait for their matching donor heart at home.

The Freedom driver weighs 13.5 lbs including two onboard lithium ion batteries and a power adaptor. It can be conveniently carried by the patient in the Freedom Backpack or Shoulder Bag. The Freedom driver is 60% lighter than SynCardia’s older CE approved “proof of concept” portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy.

The Freedom driver uses a “dark cockpit” design philosophy for simple and easy operation. Similar to an airplane cockpit, the system only flashes a light or sounds an alarm when something requires the user’s attention.

To make maintenance easier for hospitals, the Freedom driver is serviced by replacement via express delivery. No onsite repair or inventory of parts is required by the hospital.

SynCardia has also submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom driver in the U.S.

CE Mark: Design Examination Certificate (PDF)

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 CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 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.

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Source: SynCardia Systems

Issuer of this News Release is solely responsible for its content.
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