FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart
The 50cc heart is the smaller version of the 70cc SynCardia Heart, which is FDA, Health Canada and CE mark approved. It is designed for implantation in most women, smaller men and many adolescents with end-stage biventricular heart failure.
TUCSON, Ariz. – Mar. 31, 2015 – SynCardia Systems, Inc. has received FDA approval to conduct an Investigational Device Exemption (IDE) clinical study on the effective use of its 50cc SynCardia temporary Total Artificial Heart.
The FDA approval will allow SynCardia to launch the study with as many as 30 heart failure patients. Patients enrolled in this study will receive the 50cc SynCardia Total Artificial Heart as a bridge to a donor heart transplant. (CAUTION – In the United States, the 50cc SynCardia temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.)
“This study will allow smaller patients who can’t fit the 70cc Total Artificial Heart to benefit from SynCardia’s Total Artificial Heart technology,” says Michael P. Garippa, President and CEO of SynCardia Systems, Inc. “Together, both device sizes are intended to make Total Artificial Hearts available to most women and men as well as many adolescents.”
Under the study, the 50cc SynCardia Total Artificial Heart initially will be available for implantation in
- 10 pediatric patients 10-18 years old
- 10 adult patients 19-75 years old
- 10 patients who would not otherwise qualify under the study criteria. This secondary arm is expected to further characterize the use of the 50cc SynCardia Heart.
All patients in the study must be eligible for donor heart transplant.
As part of the study and to better understand the patient populations that can benefit from the 50cc SynCardia Heart, images of the patients’ chest cavities will undergo 3D modeling.
The SynCardia Total Artificial Heart is the only approved device that eliminates the source of end-stage biventricular heart failure in which the native heart’s two ventricles can no longer pump enough blood for the patient to survive.
Study data through the first six months of patient use will be provided to the FDA as part of its review and approval process. Patients will be followed for up to two years to report on their experiences.
In Europe, both sizes of the SynCardia Total Artificial Heart have CE mark approvals for use as a bridge to donor heart transplant or as destination therapy, also known as permanent use. Use of the SynCardia Heart for destination therapy varies by country.
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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,400 implants of the SynCardia Total Artificial Heart account for over 400 patient years of life on the device. Since January 2010 more than 550 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 200 patients, accounting for over 130 years of support.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463