CardioWest(TM) temporary Total Artificial Heart (TAH-t): Letter to the Editor.TUCSON, Ariz. -- 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. (NEJM NEJM New England Journal of Medicine 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 (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. Transplant Center. SynCardia is in the process of preparing an FDA submission to use the portable drivers in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The portable driver is about the size of an attache ATTACHE. Connected with, attached to. This word is used to signify those persons who are attached to a foreign legation. An attache is a public minister within the meaning of the Act of April 30, 1790, s. 37, 1 Story's L. U. S. 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. Respectfully, Donald Isaacs Director of Communications Director of Communications is a position in the private and public sectors. The Director of Communications is responsible for managing and directing an organization's internal and external communications. SynCardia Systems Inc. For a photo of the Excor TAH-t portable driver: http://www.syncardia.com/fourimages/excor.html For a photo of the CardioWest(TM) temporary Total Artificial Heart: http://www.syncardia.com/fourimages/taht.html For photos of Bill Wohl, TAH-t recipient and Transplant Olympics Medalist: http://www.syncardia.com/fourimages/billwohl2.html http://www.syncardia.com/fourimages/billwohl.html |
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