French firm Carmat announced that it had implanted its artificial heart in a 58-year-old in December, making the fourth person to receive the implant. The company is now announcing that the patient died for reasons unrelated to the functioning of the device.
|The Carmat artificial heart|
Artificial heart maker Carmat has announced that the first person to receive its artificial heart has died. After being implanted with the device at La Pitié
Salpêtrière University Hospital, the patient died from "medical complications associated with his critical pre- and postoperative state," according to a press release.
The company now reports that its feasibility study is now complete and that it has the documentation need to pursue its next clinical trial, known as the Pivotal study.
"We were fully satisfied with the artificial heart sustained function. We know the risks associated with this type of procedure and, despite all of the team's efforts, the patient died of medical complications not related to the prosthesis," said Pascal Leprince, MD or the La Pitié Salpêtrière Hospital.
The company announced that it would begin first-in-human trials on the device beginning in 2013.
The three other patients implanted with the artificial heart have also died. The first died in December 2013--74 days after the device was implanted. He was 76 years old. The second patient, aged 69, died in May, nine months after being implanted and four months after he was dismissed from the hospital.
According to Le Monde, these two deaths were caused by small amounts of blood leaking into the device, ultimately causing a disruption of the artificial hearts' electronic engine control
The third patient died of respiratory arrest in December after suffering renal failure. The device played no role in that death.