The Airbus parent company is designing a technologically advanced artificial heart for a spin-off company like Carmat SAS. Within three years, the device could be validated for use on humans.
For more than 15 years, European Aeronautics Defense & Space – better known as EADS – the parent company of aircraft manufacturer Airbus, has been working on a secret project that was “more difficult to manufacture than to go to the Moon”, according to its instigator, the famous French heart surgeon Alain Carpentier.
The mission? Develop a highly innovative artificial heart for humans. By tapping into the aerospace industry’s modeling, extreme testing, miniaturization, and design of harsh environments – as well as the latest advances in medicine, biology, and materials science – researchers at EADS had earlier hoped to go well beyond (and not entirely succeed) devices like the famous Jarvik artificial heart, the first of its kind to be implanted in humans in the early 1980s.
On October 27, the fruit of EADS’ long labor was finally unveiled at a press conference in Paris, and scientists say the new device could represent a major breakthrough for the millions of people around the world who suffer cardiovascular diseases, from which more than 10 million people die each year. Among the heart’s advantages over its predecessors: it employs two internal pumps to move blood to the lungs and through the body, rather than the single pump typical of older designs.
The ingenuity of European technology
Now that the artificial heart has been announced, responsibility for it will be given to EADS’ new spin-off company named Carmat – a merger of the names Carpentier and Matra, a French engineering company which was absorbed by EADS in 2000. EADS will keep its shares in the company, which will be financed, in a larger part, by the French investment company Truffle Capital. Carmat is about to start clinical trials, and pending approval from French medical authorities, the artificial heart could be implanted in the first human patient within three years.
For Carpentier, at the age of 75, it was the realization of a lifelong dream and the final touch of a career that made him the most famous cardiologist in France. He is particularly pleased with the fact that it is a European invention. About 30 years ago, the doctor had asked for the financing and the realization of a revolutionary invention: the world’s first biomechanical heart valves. He then had to cross the Atlantic to find a partner in Edwards Lifesciences. Carpentier Edwards valves, which are made from chemically treated pig aortic valves, are now the world leader in the $800 million annual valve replacement market. This time, thanks to EADS and other European investors.
Independent experts say that the design of the Carmat artificial heart aims to have a big lead over the alternatives developed in the United States and Asia. Two American companies, Abiomed and MagScrew, are already making artificial hearts, and other prototypes have been developed in Japan and Korea. “The Carmat core probably represents a significant step forward. says Dr. Robert Kormos, head of the artificial heart program at the University of Pittsburgh and board member of the American Society of Transplant Surgeons, who is unrelated to the project and has no not informed of the device. “If the allegations turn out to be true, they have a device that has a huge advantage over current technology. »
software and sensors
The Carmat device can already claim to be the most accurate replica of the anatomy, size and function of a real heart. A real heart, for example, has two ventricles, chambers that pump venous blood to the lungs and oxygenated blood to the body. The Carmat heart similarly has two pumps that play the same role – a first for an artificial device. “Until now, it has been difficult to get enough room in the body to actually do push-ups for the right and left sides of the heart. said Pouletty.
The heart of Carmat also materializes another first: the use of internal membranes made from a combination of polymers and biological materials. With a ventricular design that minimizes blood turbulence, these advanced internal materials are expected to minimize the creation of blood clots that can travel from the heart to the brain and cause strokes. These clots are the main reason for the existence of artificial hearts, which have had limited success to date. And, by preventing clotting, the Carmat Heart means patients go without blood-thinning medication for the rest of their lives.
Perhaps the biggest breakthrough of the Carmat heart is the use of state-of-the-art software and sensors to adjust its own performance. Depending on the patient’s level of exertion, the heart regulates its speed and blood pressure to provide more oxygen to the body. This allows for more normal physical exercise, and varies depending on whether the patient is in a seated position, climbing stairs, or taking a brisk walk. Integrated software will allow the device to be monitored and diagnosed remotely, saving patients frequent trips to the hospital for routine checkups.
“Patients with the Carmat heart will also likely benefit from more autonomy than recipients of previous devices,” says Pouletty. Current alternatives allow patients only half an hour of freedom to shower or perform other limited tasks before having to recharge a battery sewn under their skin or connect to an external power source. The Carmat heart not only uses less energy, but can also operate using internal and external rechargeable batteries allowing an autonomy of 5 hours. The company hopes to eventually exploit new energy sources such as fuel cells to further increase range.
Designed to “take off” without failure
For it to be safe, engineering challenges remain. The current Carmat prototype is suitable for the chest cavity of only 70% of patients, mainly males. The device will need to be shrunk before it can be used by smaller women and men. And while tests have already been performed on sheep and calves, problems could arise when the device is implanted in its first human recipient.
But if the Carmat team is right, its core will have a lifetime of several years without system failure. This is because it was designed using the same spirit as for an aeronautical project. “When you develop an aircraft or a missile, the first time it takes flight, it has to fly flawlessly. said Pouletty. Material durability is key. “If the primary technology fails, you need a secondary system that engages in a hundredth of a second so your plane doesn’t break down in the sky. said Pouletty. “It’s the level of engineering that is required for such a complex medical device. »
Carpentier, who filed his first patent for an artificial heart in 1986, first convinced the late French industrialist Jean-Luc Lagardère, former chairman of EADS, to support his project two decades ago. Matra, a French aeronautical company, reinforced its support for the work in 1993, helping Carpentier to validate the key concepts in an industrial environment. A full-time team of aerospace engineers and biologists was set up in 2001 at EADS, in the offices of Suresnes, a suburb of Paris along the Seine.
The 12-member team are now recruits from Carmat, which will be chaired by Jean-Claude Cadudal, former international vice-president of EADS. The company received an initial capital injection of 40 million euros, including 5 million euros from Truffle Capital, 2.25 million euros from EADS and a foundation set up by Carpentier, and 33 million from euros in grants from OSEO, a French government body that finances innovative projects. Carmat hopes to get tens of millions more over the next few years.
The biggest potential market
Its immediate goal is to develop around 20 artificial hearts that can be implanted in patients over the next two years. Initially, the device will be granted only to people who have no other recourse to stay alive. Today, there are tens of thousands of people waiting for transplants, but not enough human hearts to go around. “In France, for example, at least 10 times more heart transplants could be performed each year if surgeons had access to a viable artificial device. said Carpentier. The cost of the Carmat heart is expected to be slightly less than a human heart transplant, which costs an average of $250,000 in the United States and an additional $20,000 per year for follow-up treatment.
If the chances of survival and lifespan in patients who would die without the use of the artificial heart proves satisfactory, the market for the Carmat heart could be expanded to include a wider variety of patients with less urgent heart problems, who today are mainly helped by vascular assist devices, says Pouletty. “If that’s the case,” he adds, “the potential market would be not just hundreds of millions of dollars, but billions. »
