Healthcare Industry News:  Artificial Heart 

Devices Cardiology

 News Release - April 19, 2007

CardioWest(TM) Temporary Total Artificial Heart (TAH-t) Manufacturer, SynCardia Systems, Inc., to Unveil New Companion Universal Driver System and Family of Future Pulsatile Devices at ISHLT, April 25-28 in San Francisco

New Products Include: Universal Companion Driver for OR, ICU and Discharge, 60cc VAD, 30cc VAD, 10cc VAD and a 50cc TAH-t

TUCSON, Ariz.--(HSMN NewsFeed)--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 models of planned products currently in development, including a 50cc TAH-t and 60cc, 30cc and 10cc VADs. 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.

Source: SynCardia Systems

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