* 76-year-old patient died after 75 days with the implant
* Cause of death has yet to be established - hospital
* Carmat says it's too early to draw conclusions
* Three more patients will be fitted with the device
By Natalie Huet
PARIS, March 3 The first patient fitted with an
artificial heart made by the French company Carmat
has died, the hospital that had performed the transplant in
December said on Monday.
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.
"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 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 capitalisation
of around 407 million euros.