PARIS – A research team led by the French surgeon who re-engineered mitral valve repair said it will implant up to 20 artificial hearts in patients in 2011.

At a press conference in Paris, Alain Carpentier, MD, said, “We are moving from pure research to clinical applications. After 15 years of work, we are handing over to industry to produce an artificial heart usable by man,” according to Agence France Press.

Few medical devices begin life with such an impressive pedigree.

Carpentier was given carte blanche from the European space and defense group EADS, which estimates it already has spent more than €15 million bringing the project to a prototype stage.

The heart device is pre-approved by the French Agency for Healthcare Product Safety (AFSSAPS) for implantation in “life-threatened patients with no other available treatment options,” meaning a patient who otherwise might drop dead of a massive heart attack.

The French innovation agency OSEO awarded the company transferring the technology from the labs to the market some €33 million in grants and loans, the largest amount of funding ever awarded to a start-up.

And the new company, Carmat SAS, raised in excess of €7 million in a first financing round, with €5 million from Truffle Capital (Paris) and €2.25 million from EADS and the Fondation Alain Carpentier.

“It’s nice to have more cash than you plan to burn,” Dr. Philippe Pouletty, the managing director of Truffle, told Medical Device Daily.

“We have not done any detailed market studies,” he said.

The partners believe simply that if the implanted heart results in low survival rates and a low quality of life for the patients, then the market prospects will be low.

“Yet if this is successful with a high survival rate, we believe the potential is very high,” Pouletty said. “As far as we know, there is no other project to create an artificial heart that combines all of these factors, though we sincerely hope there will be, as there is a tremendous medical need.”

At the Paris press conference, the partners said they estimated the shortfall in heart donors to patients awaiting a transplant will reach 20,000 by 2011.

One of the primary indications for the Carmat heart will be serving as a bridge to transplant for patients who are expected to receive a heart within a one-year to two-year period, said Pouletty.

Accelerated testing of the device encourages the partners to believe the heart’s components, including power supply, can function for over three years and as high as five years.

The third indication for the device is elegantly stated as a “destination therapy for long-term use.”

According to AFP, the partners acknowledged that several teams around the world are developing fully implantable artificial hearts including the AbioCor from the American company Abiomed (Danvers, Massachusetts), which was used in 14 trials between 2001 and 2004, with patients surviving an average of 5.3 months.

Affiliated with the Georges Pompidou Hospital in Paris, Carpentier is credited with ushering in the modern era of valve reconstruction as the inventor of the Carpentier-Edwards mitral porcine valve, or bioprosthesis, as he prefers to call it.

He also developed the the Carpentier-Edwards ring, and a surgical technique called the “French correction,” designed to avoid a prosthesis altogether.

In 1993, Dr. Carpentier approached French industrialist Jean-Luc Lagadere to solicit his support for the heart project.

As Pouletty told the story to MDD, Carpentier had successfully operated on a few friends of Lagadere and won the unconditional support of the founder of EADS.

Carpentier “thought the device would be too complicated for a traditional medical technology approach with its complex electronics, high-technology and a compact design,” Pouletty said.

In other words, creating this heart was going to be rocket science, so who better to develop it than scientists who build compact, stand-alone remote systems such as satellites and the onboard electronics for missiles.

“Especially systems with onboard back-up in the event one of the systems fails,” said Pouletty.

“The EADS team has overcome many challenges,” he said, including designing an independent operation of two ventricles with separate ejection flows, inventing sensors to regulate blood flow and pressure, solving problems such as low heat production for the unit, low energy consumption, and managing blood clotting, the first adverse event resulting from any heart device implantation.

The Carpentier valve design team brought an expertise for placing biologic membranes on the inside of the heart while the EADS team engineered synthetic polymers membranes for the exterior, Pouletty said.

The prototype, which has been tested in animals, is shaped like a human heart and mimics the dynamics of heart pressures and flows, with a sensitivity to patient activity and orientation, such as standing or lying down.

The device runs off a belt-mounted battery pack for five hours, and built-in software allows it to be remotely monitored and diagnosed.

The Carmat prototype is patented and the device is now undergoing pre-clinical testing and fine-tuning, with the next milestone to be a design freeze ahead of evaluation, Pouletty said.

A management team will be put in place over the next 12 months to bring the device to market, he said, including converting a bench-built prototype to a manufacturable model.

The Carmat heart “opens the field for autonomous, self-regulating, complex bioprosthese, a very broad area in the interventional medicine of the future,” said Pouletty.