Carmat aims for EU approval of artificial heart by early 2015
Paris: Carmat hopes to finish human trials of its artificial heart by the end of next year and to obtain regulatory approval for an EU launch by early 2015, its chief executive told Reuters.
The French company is also seeking a partner in the United States to enter the world's largest healthcare market, and is in contact with Johnson & Johnson, Medtronic, St Jude Medical and Edwards Lifesciences, Marcello Conviti said.
Heart assistance devices have been in use for decades as a temporary solution for patients awaiting a transplant but Carmat's product is designed to replace the heart for up to five years, mimicking nature's work using biological materials and sensors. It targets the thousands of patients who die each year while waiting for a donor.
Carmat estimates around 100,000 patients in the United States and Europe could benefit from its artificial heart, which would make the market worth more than 16 billion euros ($21.5 billion).
In September, Carmat got the green light from French authorities to test the first human implants of the device on four patients in three French hospitals.
Earlier this year, it won approval to proceed with human implants in Belgium, Poland, Slovenia and Saudi Arabia.
"For now the tests are going as planned," Conviti said in an interview on Thursday.
He would not give details but said patients selected suffered from terminal heart failure and had only a few days or weeks to live.
On these high-risk patients, the first range of tests will focus on the device's safety, with success based on whether patients survive within a month of wearing it. If deemed safe, the devices will then be fitted into lower-risk patients and their efficacy monitored for about six months.
"If all goes well, both phases should be completed by the end of 2014," Conviti said, adding that if the results were positive, he hoped to obtain regulatory approval to launch EU-wide within two months. He said he hoped to receive this approval in late 2014 or early 2015.
SCOUTING U.S. PARTNERS
Conviti said Carmat has enough funding to cover the current clinical trials until the end of 2014. But if it secured a launch in Europe, it would ramp up efforts to get approval in the United States, where it is already looking for partners, he said.
"All the major companies active in heart surgery, such as Johnson & Johnson, Medtronic, Edwards, St Jude... are interested in widening their patient base. We are in contact with these companies," he said.
Developed by a team of engineers from Airbus parent company EADS, the Carmat device - which weighs about 900g and should cost between 140,000 and 180,000 euros in Europe - mimics heart muscle contractions and contains sensors that adapt the blood flow to patient's moves.
Power comes from external, wearable lithium-ion batteries. Inside the heart, surfaces that come into contact with human blood are made in part from bovine tissues 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 - which weighs nearly three times more than an average healthy human heart - means it can fit in 86 percent of men but only around 20 percent of women.
But Conviti said Carmat could easily manufacture a smaller version that would fit the smaller bodies of women but also of the populations of India and China.
Among its competitors for artificial heart implants are privately-held SynCardia Systems and Abiomed, both of the United States.