* Operation performed on Wednesday went smoothly - Carmat
* Male patient is awake and talking, in intensive care
* Carmat's heart aims to mimic real heart for up to 5 years
By Natalie Huet
PARIS, Dec 20 France's Carmat said on
Friday it had carried out its first implant of an artificial
heart that can beat for up to five years, adding that the
operation had gone smoothly.
The implant operation was performed on Wednesday at the
Georges Pompidou European Hospital in Paris, the biomedical firm
said in a statement. It said that the male patient was awake and
talking and he was being monitored in the intensive care unit.
"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", said Carmat's CEO, Marcello Conviti.
Heart-assistance devices have been used for decades as a
temporary solution for patients awaiting transplants, but
Carmat's bioprosthetic product is designed to replace the real
heart over the long run, mimicking nature's work using
biological materials and sensors.
It is aimed at helping the thousands of patients who die
each year while awaiting a donor, and reducing the side-effects
associated with transplants.
"It's about giving patients a normal social life with the
least dependence on medication as possible," Alain Carpentier,
surgeon and Carmat co-founder, told France 2 television.
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).
"We already had devices of this type but they had a
relatively low autonomy. This heart will allow for more movement
and less clotting. The study that is starting is being very
closely watched in the medical field," Patrick Nataf, head of
heart surgery at Paris Bichat hospital, told BFM TV.
France's Health Minister was quick to tout the operation as
a sign of the country's edge in the field of healthcare.
"This news brings great pride to France," Marisol Touraine
told BFM TV. "It shows we are pioneers in healthcare, that we
can invent, that we can carry an innovation that will also bring
great hope to plenty of people."
Among Carmat's competitors for artificial heart implants are
privately-held SynCardia Systems and Abiomed, both of
the United States.
"We're very happy for them and we wish them the best in
their pursuit," said a spokesman for SynCardia, whose artificial
heart is the only one approved both in the United States and the
European Union and has been implanted over 1,200 times.
The longest a patient has lived with SynCardia's heart is
just under four years.
THREE TIMES HEAVIER THAN A HEALTHY HEART
In September, Carmat got the green light from French
authorities to test the first human implants of the device on
four patients in three hospitals. Earlier this year, it won
approval to proceed with human implants in Belgium, Poland,
Slovenia and Saudi Arabia.
The Paris patient is the first worldwide to be implanted
with the device, Carmat said. The patients selected for the
trials suffer from terminal heart failure and the success of the
device will be judged on whether they survive with the implant
for at least a month.
Conviti told Reuters last month Carmat hoped to finish human
trials of the heart by the end of next year and to obtain
approval to market them in the EU by early 2015.
The Carmat device, developed by a team of engineers from
Airbus parent company EADS, weighs about 900g (around 2
lb)- nearly three times more than an average healthy human
heart. It is expected to cost 140,000 to 180,000 euros in
It mimics heart muscle contractions and contains sensors
that adapt the blood flow to the patient's moves.
It is powered by external, wearable lithium-ion batteries.
Inside the heart, surfaces that come into contact with human
blood are made partly from bovine tissue instead of synthetic
materials such as plastic that can cause blood clots.
Patients that will be implanted with Carmat's devices are
more likely to be men. Heart failure affects more men than women
and the sheer size of the artificial heart means it can fit in
86 percent of men but only around 20 percent of women.
But Carmat says it could easily manufacture a smaller
version to fit the smaller bodies of women as well as patients
in India and China.
Carmat's shares have risen five-fold since floating on the
Paris stock market in 2010, giving the company a market
capitalisation of about 436 million euros.