For more than 15 years, European Aeronautics Defence & Space (EAD.PA)—better known as EADS, the parent company of passenger jet maker Airbus—has been working on a secret project that was "more difficult than putting a man on the moon," according to its instigator, renowned French heart surgeon Alain Carpentier.
The mission? To develop a vastly improved artificial heart for humans. By tapping into the aerospace industry's expertise in modeling, stress testing, miniaturization, and design for severe environments—plus the latest advances in medicine, biology, and materials science—the EADS researchers aimed to go well beyond earlier (and not entirely successful) devices such as the famous Jarvik artificial heart first implanted in humans in the early 1980s.
On Oct. 27, the fruits of EADS's long labor were finally unveiled at a Paris press conference, and scientists say the new device could represent a major breakthrough for the millions of people around the world who suffer from cardiovascular diseases, of whom more than 10 million die every year. Among the heart's advantages over predecessors: It employs two internal pumps to move blood to the lungs and into the body, rather than the single pump typical of earlier designs.
The new design also uses cutting-edge biopolymer materials that promise to reduce the formation of dangerous blood clots—a persistent problem with early artificial hearts—and may even spare patients from needing to use nettlesome anticoagulant drugs. And feedback sensors and software can adjust the heart's speed and pressure depending on the exertion level of the wearer, permitting a vastly greater range of physical activity. "The only thing a patient will not be able to do is run the marathon," says Carpentier.
European Tech Ingenuity
Now that the artificial heart has been announced, responsibility for it will be passed to a new EADS spin-off called Carmat—the name is a fusion of Carpentier and Matra, a French engineering company that was absorbed into EADS in 2000. EADS will retain minority ownership in the company, which also will be funded by French venture investment firm Truffle Capital. Carmat is on the verge of starting clinical trials, and pending the approval of French medical authorities, the artificial heart could be implanted in the first human patient within three years.
For Carpentier, 75, it's the realization of a lifelong dream and the capstone of a career that has made him the most famous cardiologist in France. He's especially gratified that the invention is European. Some 30 years ago, when the doctor sought to finance and produce his breakthrough invention of the world's first biomechanically engineered heart valves, he had to cross the Atlantic to find a partner in Edwards Lifesciences (EW). Carpentier Edwards valves, which are made from preserved porcine aortic valves, are now a recognized leader in the $800 million annual replacement valve market. This time around, thanks to EADS and other European investors, Carpentier didn't need U.S. help—a sign of Europe's growing support for riskier tech innovation.
Independent experts say the design of the Carmat artificial heart looks to have a big lead over existing alternatives developed in the U.S. and Asia. Two U.S. companies, Abiomed (ABMD) and MagScrew, already make artificial hearts, and other prototypes have been developed in Japan and Korea. The Carmat heart may be "a significant advance," says Dr. Robert Kormos, head of the artificial heart program at the University of Pittsburgh and a board member of the American Society of Transplant Surgeons, who isn't connected with the project and hasn't been briefed on the device.
"If the claims prove to be a reality, they have a device that has a substantive benefit over the current technology that exists."
The breakthroughs in the Carmat heart owe much to recent high-tech advances, including medical imaging and computer modeling. These tools also are expected to aid the development of other "bio body parts" such as artificial kidneys and livers within the next 30 years, says Philippe Pouletty, a trained medical doctor and general partner at Truffle Capital. But hearts are likely to be the first organs to be perfected, notes Patrick Coulombier, a member of the secret EADS heart team since 2001 and now the chief operating officer for Carmat.
Software and Sensors
The Carmat device can already claim to be the closest to mimicking a real heart's anatomy, size, and function. A real heart, for instance, has two ventricles, the lower chambers that pump deoxygenated blood to the lungs and oxygenated blood out 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 have enough room in the body to have effective pumps for the right and left sides of the heart," says Pouletty.
Carmat's heart also scores another first: the use of internal membranes made from a combination of polymer and biological materials. Along with a ventricular design that minimizes blood turbulence, these cutting-edge internal materials should minimize the creation of blood clots that can travel from the heart to the brain and cause strokes. Such clots are the major reason existing artificial hearts have had limited success to date. And avoidance of clotting also means that patients with the Carmat hearts may not have to take lifestyle-impairing anticoagulant drugs for the rest of their lives.
Perhaps the biggest breakthrough is the Carmat heart's state-of-the-art use of software and sensors to adjust its own performance. Depending on the patient's level of exertion, the heart adjusts its speed and blood pressure to feed more oxygen to the body. That allows for a more normal—and variable—level of physical exertion, whether the patient is sitting still, climbing a flight of stairs, or taking a brisk walk. The built-in software also will allow the device to be remotely monitored and diagnosed, sparing patients frequent trips to the hospital for routine checkups.
Carmat heart wearers also will likely enjoy more autonomy than recipients of earlier devices, Pouletty says. Current alternatives allow patients only a half-hour of freedom to take a shower or perform other limited tasks before they have to recharge a battery sewn under their skin or connect to an external energy source. The Carmat heart not only uses less power but also can be run off a belt-mounted battery pack for five hours. The company hopes eventually to harness emerging power sources such as fuel cells to extend autonomy even further.
Designed to "Launch" Without Fail
To be sure, engineering challenges remain. The current Carmat prototype fits into the chest cavity of only about 70% of patients, primarily male. The device will have to get smaller before it can be used in many women and smaller men. And although tests already have been performed on sheep and calves, problems still could crop up when the device is implanted into its first human recipient.
But if Carmat's team is right, its heart will last several years without system failure. That's because it was designed using the same mindset as for an aerospace project. "When you develop a plane or a missile, the first time it takes off it has to fly without a flaw," Pouletty says. The durability of materials is key. "If prime technology fails, you need a backup that starts in one-hundredth of a second so your plane does not break up in the sky," says Pouletty. "This is the level of engineering that is needed in such a complex medical device."
Carpentier, who filed for his first patent on an artificial heart in 1986, initially persuaded the late French industrialist Jean-Luc Lagardère, a former EADS chairman, to back his project two decades ago. Matra, a French aeronautics company, stepped up to support the work in 1993, helping Carpentier validate key concepts in an industrial setting. A dedicated full-time team including aerospace engineers and biologists was put into place in 2001 at EADS's offices in Suresnes, a suburb of Paris that borders the Seine.
The 12-member team is now moving over to Carmat, which will be chaired by Jean-Claude Cadudal, a former international vice-president of EADS. The company has received an initial capital injection of €40 million ($50 million), including €5 million from Truffle Capital, €2.25 million from EADS and a foundation formed by Carpentier, and €33 million in grants from OSEO, a French government agency that funds innovative ventures. Carmat is hoping to raise tens of millions more in private equity over the next few years.
Bigger Potential Market
Its immediate goal is to develop about 20 artificial hearts that can be implanted into patients over the next two years. At first, the devices will be given only to people who would otherwise die. Today, there are tens of thousands of people awaiting transplants, but not enough human hearts to go around. In France, for instance, at least 10 times as many heart transplants could be performed each year if surgeons had access to a viable artificial device, Carpentier says. The cost of the Carmat heart is expected to be slightly less than a human heart transplant, which averages about $250,000 in the U.S. and an additional $20,000 per year in follow-up treatment.
If the survival rate and length of survival in patients who would die otherwise proves satisfactory, the market for the Carmat heart could be enlarged to include a wider variety of patients with less urgent heart problems, who are helped today primarily by vascular-assist devices, says Pouletty. If that is the case, he adds, the potential market could be not just hundreds of millions of dollars but billions.