TUCSON, Ariz.--(BUSINESS WIRE)--A 12-year-old boy at Bambino Gesù Children’s Hospital in Rome, Italy, has become the world’s youngest patient to be bridged to a heart transplant with the SynCardia temporary Total Artificial Heart.
Diagnosed with dilated cardiomyopathy, Andrei began experiencing biventricular dysfunction in January. Two months later, he was admitted to the hospital with end-stage heart failure. The 12-year-old needed a heart transplant, but a matching donor heart wasn’t available.
To save Andrei’s life, on April 21, doctors removed his failing heart and implanted the 50cc Total Artificial Heart to restore blood flow to his body and help him get stronger for transplant. Two weeks later, Andrei received the matching donor heart he’d been waiting for.
“I use the Total Artificial Heart because it is more versatile than BIVAD support with the Berlin Heart, the only alternative, and the Total Artificial Heart permits patients to be discharged from the hospital,” said Dr. Antonio Amodeo, Surgical Director of the Heart Failure Program at Bambino Gesù Children’s Hospital. “The 50cc Total Artificial Heart was the best option based on the age and size of this patient.”
At the time of implant, Andrei was 17 days younger than the previous record-holder, a 12-year-old girl in the United Kingdom who was successfully bridged to transplant with the 50cc Total Artificial Heart in 2016.
The 50cc Total Artificial Heart is a smaller version of SynCardia’s 70cc Total Artificial Heart, the first and only heart replacement device to attain commercial approval in the U.S., Canada and Europe. Designed to fit patients of smaller stature, including more women and adolescents, the 50cc Total Artificial Heart has the CE mark for use in Europe and is undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces the failing heart and restores blood flow to the body, allowing the patient to begin their recovery from heart failure. Unlike a donor heart, the Total Artificial Heart cannot be rejected and is readily available at SynCardia Certified Centers, providing a new heart without the wait to patients with end-stage biventricular heart failure.
CAUTION – In the United States, the SynCardia 50cc TAH-t is an investigational device, limited by federal law to investigational use.
About Bambino Gesù Children's Hospital
Bambino Gesù Children’s Hospital is a scientific institute for research and health care and is Italy’s main pediatric hospital providing advanced health care for children and performing basic, clinical and translational research activities. The hospital is widely recognized as a referral center for all pediatric specialties at national and international levels. In 2015, the hospital was accredited by Joint Commission International (JCI) as an academic medical center hospital.
About SynCardia Systems, LLC
SynCardia Systems, LLC (www.syncardia.com) 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 SynCardia 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.