20 Years after Landmark FDA Approval, SynCardia Remains World's Only Commercially Approved Total Artificial Heart

Few total artificial hearts make it to human clinical trials, and only the SynCardia Total Artificial Heart has met the rigorous requirements for commercial approval.

TUCSON, Ariz., July 25, 2024 /PRNewswire/ -- Nearly twenty years ago, the SynCardia Total Artificial Heart became the first total artificial heart to receive commercial approval from the U.S. Food & Drug Administration (FDA). Since then, a number of experimental total artificial hearts have come and gone, but unlike the SynCardia Total Artificial Heart, none have been able to achieve commercial approval nor widespread clinical use.

"Completely implantable heart replacement therapy is the zenith in the world of artificial organs," said Patrick Schnegelsberg, CEO of SynCardia. "The Total Artificial Heart we have developed is the first and remains the only commercially available device. Our vision is to build on our experience and proven technology to make our dream of fully implantable technology a reality."

The SynCardia Total Artificial Heart received FDA approval on Oct. 15, 2004, following a 10-year pivotal clinical study. According to the study results, which were published in the New England Journal of Medicine on Aug. 26, 2004, of the 81 patients who received the SynCardia Total Artificial Heart, 79% were bridged to a heart transplant. In comparison, only 46% of the control patients who did not receive the device survived to transplantation.

Overall, the one-year survival rate post-transplant among the clinical study patients who received the SynCardia Total Artificial Heart was 70% compared with only 31% of patients who did not receive the device prior to receiving a heart transplant. One-year and five-year survival rates after transplantation among patients who received the SynCardia Total Artificial Heart were 86% and 64%, respectively.

More recent studies in the US and in Europe have confirmed these results in real world populations.

Today, there have been more than 2,000 implants of the SynCardia Total Artificial Heart at more than 130 hospitals across 25 countries.

Over the years, several experimental total artificial hearts have made headlines but have yet to achieve commercial success and have remained in clinical trials.

About SynCardia
The SynCardia Total Artificial Heart is the first and only commercially available FDA and Health Canada approved total artificial heart. It is available in two sizes, to accommodate a wide variety of patients providing cardiac output flows up to 9 lpm.

The SynCardia Total Artificial Heart has been implanted in over 2,000 patients across 20 countries and has provided 293,997 days of life to patients with heart failure.  Powered by the Freedom Portable Driver™, the SynCardia Total Artificial Heart has allowed many patients to live at home while waiting for a donor heart including a patient currently at home with his family who has been supported by the SynCardia Total Artificial Heart since 2017. To learn more, visit www.syncardia.com and follow us on Facebook, X, and LinkedIn.

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Vivian Highton
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SOURCE SynCardia Systems, LLC