PARIS, March 4 (Reuters) - French company Carmat said on Tuesday that it would proceed with further clinical trials in humans of its artificial heart after the death of the first patient fitted with the device.
Carmat’s first patient, a 76-year-old man, died on Sunday in Paris, two and a half months after his transplant. The hospital that had performed the operation said the cause of his death could not be known for sure at this stage.
“Carmat, first and foremost, wishes to pay tribute to the courage and the pioneering role of this patient and his family,” the group said in a statement.
“The company stresses that it is too soon to draw any conclusions from the data of a single patient, whatever the duration of the implantation.”
In an initial feasibility study, three more patients in France with terminal heart failure were due to be fitted with Carmat’s device, which is designed to replace the real heart for as much as five years. The clinical trial will be considered a success if the patients survive with the implant for at least a month.
Carmat said it was not planning to publish any information on the results of the feasibility study until a global analysis of the trial’s data was completed.
Reporting by Natalie Huet and Leila Abboud; Editing by William Hardy