July 26, 2024

20 Years after Landmark
FDA Approval, SynCardia
Remains World’s Only
Commercially Approved
Total Artificial HeartFew total artiﬁcial hearts make it to human clinical trials, and only the SynCardia Total Artiﬁcial Hearthas met the rigorous requirements for commercial approval.
TUCSON, Ariz. – July 25, 2024 – 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 andgone, 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 availabledevice. Our vision is to build on our experience and proven technology to make our dream of fully implantable technology areality.”
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. Oneyear and ﬁve-year survival rates after transplantation among patients who received the SynCardia Total Artiﬁcial Heart were86% 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 25countries.
Over the years, several experimental total artiﬁcial hearts have made headlines but have yet to achieve commercial successand 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 9lpm.

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20 Years after Landmark FDA Approval, SynCardia Remains World’s Only
Commercially Approved Total Artificial HeartThe 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 https://www.syncardia.com/and follow us on Facebook, X, and LinkedIn.

About SynCardia Systems, LLC
SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ. We manufacture and distribute theworld's first and only US Food and Drug Administration (FDA) and Health Canada approved total artificial heart. The SynCardia
Total Artificial Heart is the most widely used and extensively studied artificial heart in the world.
The SynCardia Total Artificial Heart (STAH)The STAH has been successfully implanted in over 2,000 patients suffering from advanced stage heart failure. The implant isavailable in two sizes to accommodate patients’ diverse physiologies. The STAH is approved for sale in the US and in Canada
where it is indicated for use in cardiac transplant-eligible patients at risk of imminent death from biventricular failure. EU andinternational approvals are pending. For additional information and label information, visit us at www.syncardia.com.

SynCardia Systems, LLC
1992 E. Silverlake Rd. Tucson, AZ 85713 | US
+1 520-545-1234 | info@syncardia.com
www.SynCardia.com

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About Heart Failure*
Heart failure (HF) is a growing burden for the United States and other developed countries due to the aging of their populations.
Approximately 6.7 million individuals had HF in 2023 and the prevalence of advanced stage HF has been estimated to be as
high as 25% of the total HF populations. Approximately 300,000 (5%) of advanced stage HF are refractory to guideline directedtherapy.
Medical Advice Disclaimer
The information, including but not limited to, text, graphics, images, and other components contained in this material are forinformational purposes only. No information in this material is intended to be a substitute for professional medical advice,diagnosis, or treatment. Always seek the advice of your physician or a qualified health care provider with any questions you
may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because ofinformation you have read in this material.
* Bozkurt B, et al., J Card Fail. 2023 Oct;29(10):1412-1451; (2) Abouezzeddine et al., Congest Heart Fail. 2011 Jul-Aug;17(4):160-8.

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