French company Carmat plans to conclude human trials of its artificial heart in two years and obtain permission from the EU authorities to offer the product commercially.
Designed to address the general shortage of human heart donors that costs thousands of lives of heart failure sufferers each year as suitable organs are frequently unavailable, Carmat’s elaborate system of sensors and biological materials wants to become a fully-fledged replacement.
Developed by a team of Airbus engineers, the 900g Carmat device mimics heart muscle contractions and contains sensors that adapt the blood flow to patient's moves.
Expected to cost between £117,000 and £150,000, the device will provide the patients with better prospects than currently available devices, helping them to get through the waiting period for a real heart.
The artificial heart is powered by external wearable lithium-ion batteries. The internal surfaces that come into contact with human blood are made of bovine tissues instead of synthetic materials such as plastic that can cause blood clots.
Earlier this year, Carmat received approval to start with human trials in France, Belgium, Poland, Slovenia and Saudi Arabia."For now the tests are going as planned," said Carmat’s CEO Marcello Conviti, explaining all the patients involved in the early testing were in the terminal heart failure stages and only had days or weeks of life left.
On these high-risk patients, the first range of tests will focus on the device's safety, evaluating 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 of the test completion. He said he hoped to receive this approval in late 2014 or early 2015.
The French company is also looking for partners in the US to enter the world's largest healthcare market, and is in contact with Johnson & Johnson, Medtronic, St Jude Medical and Edwards Lifesciences, Conviti said.
Carmat estimates around 100,000 patients in the US and Europe could benefit from its artificial heart, making the market worth some £14bn.
Conviti said Carmat has enough funding to cover the current clinical trials until the end of 2014.
Initially, mostly men would benefit from Carmat’s artificial heart. Weighing three times more than a healthy human heart, the devices would fit about 86 per cent of the European male population but only 20 per cent of women.
However, men are far more likely to suffer fatal heart failure than women.