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Carmat Investigates Death of First Artificial Heart Recipient

French artificial heart maker Carmat says it will not perform another human implant until it has determined the cause of death of the first patient fitted with the device.

 

That first patient, a 76-year-old man suffering from terminal heat failure, died March 2. He received the implanted artificial heart 75 days before, on December 18. The Georges Pompidou European Hospital in Paris, where the implantation was performed, announced the death.

Alain Carpentier, MD, the inventor of the heart, told the Journal du Dimanche on March 16 that the heart had stopped after a short circuit, although the exact reasons behind the death were still unknown.

“We are trying to understand where this electronic problem came from and why,” Carpentier told the French weekly. “Our engineers are working night and day to understand, and they will find (the reason).”

Velizy Villacoublay, France–based Carmat said in a news release on March 17 that it is continuing to analyze the data from the first implanted prosthesis. The company further stated that it will continue the clinical trial once it has obtained the results of the data from the first implantation.

Reuters reports that Philippe Pouletty, director general of Truffle Capital, one of Carmat's main shareholders, told i>Tele television, “Patients are still being chosen, but of course we will wait to hear a little more on the causes of the death of the first patient before transplanting another artificial heart.”

The company explained that its detailed analysis of the data is still being carried out. More than 4000 pieces of data are recorded every second, it said. These include inputs from the artificial heart itself, its control console, and their respective power supplies.

Also of great interest are the very complex interactions between the weakened heart of the patient and the prosthesis. At the current time, Carmat says, there is no single explanation, only hypotheses that will be substantiated or not in the coming weeks by in-house and external experts. The results of the analyses of the first implantation, and the subsequent implantations, will be reviewed by the Data and Safety Monitoring Board (DSMB).

From the company’s point of view, the first implantation was a success. The patient survived for 74 days within the framework of a trial where the benchmark for success was 30 days. Carmat says that the approved medical centers are continuing to assess next patients for the ongoing clinical trial.

Pouletty said that the data analysis would be complete within “a few weeks.” The company has previously stated that if it passed this first safety test, it intends to fit the device into about 20 more patients with less severe heart failure later this year. It hopes to apply for CE Marking to market its device in Europe by 2015.

 

 

Source: Stephen Levy is a contributor to Qmed and MPMN.

 

 

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