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SynCardia Systems, Inc.

About SynCardia Systems, LLC

The SynCardia Total Artificial Heart Saves Lives, and the Freedom® Portable Driver Gives Patients the Power to Live It

At SynCardia Systems, LLC our mission is to eliminate end-stage biventricular (both sides) heart failure as a leading cause of death in the modern world. When all other treatments fail, the SynCardia temporary Total Artificial Heart (TAH-t) gives patients a second chance at life.

X-Ray of the SynCardia Total Artificial Heart
Pictured, left, 70cc and, right, 50cc SynCardia temporary Total Artificial Hearts. SynCardia Systems, LLC has received FDA approval to launch an Investigational Device Exemption study into the effective use of the new 50cc SynCardia Heart.

SynCardia manufactures the first and only FDA (U.S.), CE Mark (Europe) and Health Canada approved Total Artificial Heart in the world. Similar to a donor heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and four heart valves. This eliminates the source of end-stage biventricular heart failure.

Unlike a donor heart, the SynCardia Total Artificial Heart is readily available at more than 130 SynCardia Certified Centers as a bridge to to transplant. The SynCardia Heart, powered by the Freedom® portable driver, provides clinically stable patients the opportunity to wait for their donor hearts at home and in their communities. This eliminates most in-hospital expenses and greatly improves quality of life. With hospital discharge many patients sleep in their own beds, socialize, attend religious services and some even return to work.

Today, the SynCardia Total Artificial Heart and its direct predecessors account for 96% of all artificial hearts implanted into people. Thirty-five years of research and development led to the first implant of the Total Artificial Heart into Barney Clark in 1982. Today, there have been more than 1,700 implants of the Total Artificial Heart, accounting for more than 590 patient years of life.

Each day we are working to help more heart failure patients have access to SynCardia’s life-saving Total Artificial Heart technology. Together, the 70cc approved Total Artificial Heart and the 50cc TAH-t, currently in an FDA-approved clinical study, are designed to make the SynCardia Heart available to almost all men and women and many adolescents. And for patients who don’t qualify for a donor heart transplant, the SynCardia Heart is in a separate FDA-approved clinical study for the use of the 70cc heart for permanent use – also known as destination therapy.

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