The US Food and Drug Administration has granted approval for SynCardia Systems to carry out an investigational device exemption (IDE) clinical trial for its new smaller temporary total artificial heart.
IDE clinical study will demonstrate the effective use of 50cc SynCardia temporary total artificial heart in heart failure patients.
The approval will allow the company to enroll about 30 heart failure patients in the trial, which will receive the 50cc SynCardia total artificial heart as a bridge to a donor heart transplant.
SynCardia Systems president and CEO Michael Garippa said: "This study will allow smaller patients who can’t fit the 70cc total artificial heart to benefit from SynCardia’s total artificial heart technology.
"Together, both device sizes are intended to make Total Artificial Hearts available to most women and men as well as many adolescents."
As part of the trial, the 50cc SynCardia total artificial heart will be implanted in 30 patients, including ten pediatric patients aged ten to 18 years, ten adult patients aged 19 to 75 years and ten patients that would not otherwise qualify under the study criteria.
Under the study, images of the patients’ chest cavities will undergo 3D modeling, in a bid to better understand the patient populations to benefit from the 50cc SynCardia heart.
The company will provide the study data of first six months to the FDA, as part of the review and approval process. It will monitor the patients up to two years to report on their experiences.
According to the company, 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.
Image: SynCardia has received FDA approval to launch an IDE trial into the effective use of the new 50cc total artificial heart. Photo: courtesy of SynCardia Systems, Inc.