By Natalie Huet
PARIS (Reuters) - 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 Europe.
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 capitalization of about 436 million euros.
($1 = 0.7315 euros)
(Additional reporting by Mark John; Editing by Hugh Lawson and Rosalind Russell)