Healthcare Industry News:  Artificial Heart 

Devices Cardiology

 News Release - September 12, 2006

CardioWest(TM) temporary Total Artificial Heart (TAH-t): Letter to the Editor

TUCSON, Ariz.--(HSMN NewsFeed)--Sept. 12, 2006--The following letter was issued today by SynCardia Systems Inc.:

Letter to the Editor,

We read with great interest AbioMed's news (9/5/06) concerning the FDA's granting a Humanitarian Device Exemption for their implantable Artificial Heart. A review of the subsequent media coverage could lead some to the conclusion that their product, studied in 14 human patients, is the world's:

1. First Artificial Heart

2. Only FDA approved Artificial Heart

3. Only Artificial Heart which allows patients to go home.

Every one of those conclusions is incorrect.

On October 15, 2004, SynCardia Systems Inc., manufacturer of the CardioWest(TM) temporary Total Artificial Heart (TAH-t), received the first FDA approval for an Artificial Heart. The TAH-t has been implanted in over 600 patients. The results of the pivotal clinical study on the device were published in the 8/26/04 issue of the New England Journal of Medicine (NEJM 2004; 351: 859-867).

On July 17, 2006, following a three-year study in Germany, SynCardia received a CE mark to use the Excor TAH-t portable drive system with the CardioWest(TM) TAH-t in Europe.

"The availability of a portable driver will significantly increase the use of the CardioWest(TM) TAH-t as an option for patients with refractory heart failure," explained Dr. Francis D. Pagani, director, University of Michigan Transplant Center. SynCardia is in the process of preparing an FDA submission to use the portable drivers in the United States.

The portable driver is about the size of an attache case and weighs less than 20 pounds. This driver allows stable patients to live at home, shop and have a freer, more flexible life. Patients enjoy total portability for 4-6 hours, and with a simple battery change, they can be out of the house for 8-12 hours.

Donald Isaacs
Director of Communications
SynCardia Systems Inc.

For a photo of the Excor TAH-t portable driver:

For a photo of the CardioWest(TM) temporary Total Artificial Heart:

For photos of Bill Wohl, TAH-t recipient and Transplant Olympics Medalist:

Source: SynCardia Systems

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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