EADS Unveils Innovative Artificial Heart

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"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.

Schenker is a BusinessWeek correspondent in Paris.