Reuters has reported the death of the first patient fitted with an artificial heart made by the French company Carmat following implantation of the device in December. Sad as the news is, the device has actually achieved its primary efficacy outcome by surviving over a month post-transplant.
When he was fitted with the device, the 76 year old man was suffering from terminal heart failure and was said to have only a few weeks, or even days, to live. He dies on Sunday, 76 days after the operation, although the cause of his death has not been established at the time of writing.
Carmat’s bioprosthetic device is designed to replace the real heart for as much as five years, mimicking nature’s work using biological materials and sensors. It aims to help the thousands of patients who die each year while awaiting a donor, and reducing the side-effects associated with transplants.
Back in December Carmat issued a post-implantation press release stating that the implantation had gone smoothly, with the prosthesis automatically providing blood flow at physiologic conditions. At the time Carmat CEO Marcello Conviti stated; “We are delighted with this first implant, although it is premature to draw conclusions given that a single implant has been performed and that we are in the early postoperative phase”.
While we’ve not covered Carmat on our pages before, we have followed its U.S. competitors, SynCardia Systems and Abiomed, both of whom offer devices that are intended as a bridge to transplantation.
In contrast, Carmat’s heart is designed to serve as a permanent implant, extending life for terminally ill patients who cannot hope for a real organ, generally because they are too old and donors too scarce. If you want to see a stunning animation of the device in situ, you can find one here.
Three more patients in France with terminal heart failure will now be fitted with the Carmat device and if all survive with the implant for at least a month it will then be implanted into about 20 patients with less severe heart failure.
“The doctors directly involved in the post-surgical care wish to highlight the value of the lessons learned from this first clinical trial, with regard to the selection of the patient, his surveillance, the prevention and treatment of difficulties encountered,” the hospital said in its statement.
An in-depth analysis of the medical and technical data gathered since the patient’s operation will be needed to establish the cause of his death, the hospital added.
“Carmat wishes to pay tribute to the courage and the pioneering role of this patient and his family, as well as the medical team’s dedication,” a company spokeswoman said.