Press Release:

TUCSON, Ariz. – April 12, 2007 – SynCardia Systems, Inc., manufacturer of the world’s only FDA and CE Mark approved temporary Total Artificial Heart (TAH-t), is announcing the availability for clinical investigation of a portable driver that is designed to allow stable U.S. patients to recover at home while they wait for their donor heart for transplant.

“The Companion Driver is the first pulsatile driver intended to fully support patients from implant through discharge and back to the hospital for transplant,” explains SynCardia’s CEO and President, Rodger G. Ford.

For OR and ICU applications, the Companion Driver is designed to be docked into a hospital cart that features a large 15” monitor intended to be viewed from across a room. For stable patients to be discharged, the Companion Driver is designed to be “re-docked” into a smaller caddy that features large wheels and an adjustable handle intended to facilitate patient mobility. The Companion Driver is designed to function in both hospital and discharge environments.

“The Companion has been designed to be an adaptable driver,’” said Dr. Marvin Slepian, SynCardia’s Chairman.

“SynCardia is leading the technology curve. This driver is intended to support not only the world’s only TAH-t, but also the planned SynCardia family of pulsatile devices that are currently in development.”

SynCardia met with FDA in March to informally review the company’s plan to submit an application to conduct an IDE clinical trial of the Companion Driver at U.S. transplant centers.

All nine TAH-t Certified Centers in the U.S. including Cleveland Clinic, Hospital University of Pennsylvania, Ohio State, University of Michigan, etc. have expressed interest in being considered for participation in this clinical trial. U.S. transplant hospitals interested in being part of the clinical study should contact the SynCardia Director of Global training and support, Mary Pat Sloan.

Sloan and the entire SynCardia management team will be available at the SynCardia ISHLT booth. This year’s display will feature the Companion Driver, Hospital Cart and Discharge Caddy along with a model of a 50cc TAH-t currently under development. The booth will also feature a High Definition time-lapse video of a TAH-t implant surgery filmed by National Geographic photographer Robert Clark. The surgery was conducted at the German Heart Center Berlin by Professor Roland Hetzer.

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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, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 250 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

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