The total artificial heart, called Aeson , is now available in Europe. This Thursday, the French company Carmat announced its first human artificial heart implant in the United States, as part of a clinical study. The procedure was performed at Duke University Hospital in Durham, North Carolina.
Three other study centers have been established in the United States and are in the process of selecting trial candidates. Ten eligible patients must be recruited for the US Food and Drug Administration-approved study.
The Carmat device is intended for people with end-stage heart failure , which can usually only be treated with a heart transplant. The CARMAT device differs from previous designs in that it is intended to be used in end-stage heart failure, rather than as a bridge device while the patient awaits a transplant. At 900 grams it still weighs almost three times more than the typical heart and is aimed primarily at obese men.
Carmat’s mechanism is designed to replace the natural heart for approximately 5 years, mimicking its work with biological materials and sensors.
On April 4, 1969, the first artificial heart transplant was performed. The artificial heart was developed in Dr. DeBakey’s laboratory at Baylor, with funding from the National Heart Institute. The device was made of plastic fiber and Dacron (a type of man-made polyester), weighed 227 grams, and was attached by several plastic tubes to a control console at the head of the patient’s bed.
Given the use of highly biocompatible materials, its unique self-regulating system and its pulsatile nature, the CARMAT total artificial heart could, assuming successful clinical development, potentially save the lives of thousands of patients each year with no risk of rejection and better quality of life.