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 The 76-year-old man died on Sunday, 75 days after
the operation, the Georges Pompidou European Hospital in Paris said
in a statement, adding that the cause of his death could not be
known for sure at this stage.
When he was fitted with the device, the man was suffering from
terminal heart failure, when the sick heart can no longer pump
enough blood to sustain the body, and was said to have only a few
weeks, or even days, to live.
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.
"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.
She stressed that it was premature to draw any conclusions on
Carmat's artificial heart at this stage.
Three more patients in France with terminal heart failure are due to
be fitted with the device. The clinical trial will be considered a
success if the patients survive with the implant for at least a
month.
If it passes the test, Carmat has said it would fit the device into
about 20 patients with less severe heart failure.
EXTENDING LIFE
"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.
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Carmat estimates around 100,000 patients in the United States and
Europe could benefit from its artificial heart, a market worth more
than 16 billion euros ($22 billion).
Among Carmat's competitors for artificial heart implants are
privately-held SynCardia Systems and Abiomed, both of the United
States.
SynCardia's artificial heart is the only one approved both in the
United States and the European Union and has been implanted in more
than 1,200 patients to keep them waiting for a heart from a matching
donor. The longest a patient has lived with the device is just under
four years prior to a transplant.
Carmat's heart is designed to serve not as a bridge to transplant
but 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.
Carmat's shares, which have risen nearly five-fold since floating on
the Paris stock market in 2010, closed at 95 euros before Monday's
news, giving the company a market capitalization of around 407
million euros. ($1 = 0.7260 euros)
(Editing by Michel Rose and Kevin
Liffey)
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