The first transplant using an artificial heart produced by the French biomedical company Carmat took place in the United States, it was confirmed on July 15.

The procedure was performed at Duke University Hospital in Durham (North Carolina), one of the largest American cardiac centers.

“This clinical study will help us determine whether the properties of the device are beneficial for patients who currently have very few options,” said Dr. Carmelo A. Milano, one of the cardiac surgeons involved, quoted in the press release. Carmat press.

A total of 10 patients are expected to participate in this latest clinical study, in order to meet the requirements of the United States Food and Drug Administration.

Three other cardiology centers have therefore received training in preparation and are currently in the process of selecting patients to join the study.

This first clinical trial in America will be “vital for our expansion into the world’s largest medical device market,” said Stéphane Piat, CEO of Carmat.

Progress reports on the first three transplant patients will be compiled after 60 days, before the next seven patients are recruited, Carmat said.

Clinical trials in France

the first Carmat heart transplant in France was completed in December 2013. Testing was halted after the death of France’s first artificial heart transplant patient in 2014, but quickly resumed.

Problems with the device that contributed to the eventual death of the first two patients have been revealed as electronic component failures that have since been corrected, Le Point reported.

Carmat heart now CE marked medical device

Known as “Aeson”, the world’s most advanced total artificial heart was invented by French heart surgeon Alain Carpentier.

European CE certification was obtained in December 2020, which means that it can now be marketed in countries that require this marking.

France and Germany should be among the first to adopt them.

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