Healthcare Industry News: SynCardia Systems
News Release - June 18, 2009
800th Implant of World's Only Approved Total Artificial Heart Performed by Heart and Diabetes Center NRWGerman Hospital Pioneered First Discharge Driver for Stable European Total Artificial Heart Patients
TUCSON, Ariz.--(HSMN NewsFeed)--On June 12, the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, performed the 800th implant of the SynCardia temporary CardioWest™ Total Artificial Heart. The 60-year-old patient, who was suffering from biventricular failure, was listed in stable condition post-implant.
“This was our 129th implant of the Total Artificial Heart,” said implanting surgeon Dr. Latif Arusoglu. “The Total Artificial Heart is the only device that pumps up to 9.5 L/min through both ventricles, helping us to rescue the sickest of the sick.”
Dr. Arusoglu brought the Total Artificial Heart to the Heart & Diabetes Center NRW and performed the hospital’s first implant in 2001. As an instructor for SynCardia’s Certification Program, Dr. Arusoglu proctors top European transplant centers during their first implant. The Heart & Diabetes Center NRW has performed more Artificial Heart implants than any other center in Germany.
“Our Total Artificial Heart patients can wait up to 2 years for a matching donor heart,” explained Prof. Jan Gummert, M.D., Director of the Clinic for Thoracic and Cardiovascular Surgery. “The portable driver allows stable patients to enjoy an active lifestyle at home and in their communities, similar to people with healthy human hearts.”
From 2003-2006, the Heart & Diabetes Center NRW pioneered the clinical study of the European portable driver, which resulted in the CE Mark. European Total Artificial Heart patients discharged on the portable driver account for more than 50 years of life outside the hospital without a human heart.
In the U.S., an FDA-approved discharge driver has never been available. Total Artificial Heart patients - who are otherwise healthy - often spend months confined to the hospital while they wait for a matching donor heart.
This summer, SynCardia will submit an application to the FDA to conduct an IDE clinical study of the new 12-lb Freedom™ discharge driver. Once the study is approved, for the first time in U.S. history, stable Total Artificial Heart patients will be able to leave the hospital and enjoy life at home while they wait for a matching donor heart.
Originally designed as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for patients 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.
The SynCardia Total Artificial Heart is the first and only FDA, Health Canada and CE approved Total Artificial Heart in the world. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 170 patient years of life on the device.
Source: SynCardia Systems
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