An artificial heart developed by French cardiac specialist Alain Carpentier, emeritus professor of the University of Paris-6, Pierre et Marie Curie, is to be marketed by Carmat SAS, an innovative start-up company launched last month. The prosthetic device, which is both anatomically and functionally similar to the human heart, should be ready for commercial production by 2013.


The battery-operated heart has been developed over the past 15 years by Carpentier with collaboration of the EADS group - better known as the manufacturer of the European Airbus - which contributed millions of euros and provided a team of engineers. Their joint research combined expertise in several fields of medicine and cutting-edge technologies to result in the world's most advanced artificial heart.

The 900-gram prototype is designed to last for the rest of a patient's life rather than, as with existing models, to act as a stopgap for those awaiting a transplant. It is composed of materials which do not trigger rejection or generate clots.

Carpentier is a member of the French Academy of Sciences; he founded and still manages the heart transplant and prostheses laboratory of Paris-6 University. He is also a professor at Mount Sinai School of Medicine in New York and won the 1998 Foundation for Medical Research Prize, and the 2007 Albert Lasker clinical medical research award for the invention of the first valve bio-prostheses (Carpentier-Edwards valves) and development of techniques for plastic and reconstructive surgery of heart valves.

Carmat SAS, a spin-off from the Carpentier-EADS collaboration, also includes as founding partner Truffle Capital, an independent European private equity firm that invests in technology in IT, life sciences, and energy and sustainable development. Carmat has additional funding from French innovation agency OSEO.

The company has so far raised more than EUR7 million (US$8.8 million) of which EUR5 million is from Truffle, while OSEO has awarded EUR33 million in grants-in-aid and loans. Depending on its progress and needs, the company will seek future additional international investments.

Other project partners include surface engineering specialist HEF R&D; VAI, manufacturer of high-precision production of small mechanical parts, Dedienne Santé, producer of orthopaedic surgical implants, and Paxitech, specialist in portable fuel cells.

Carmat's prosthesis heart has been patented and is currently undergoing preclinical trials. It meets the human body's biocompatibility criteria and is anatomically and functionally similar to the human heart. Clinical trials are scheduled for 2011, followed by commercialisation in 2013.

"At present we have a prototype which is potentially implantable in humans and whose components have already been evaluated on the test bed over the equivalent of several years' operation." said Carpentier. "Once we have approval from the French Agency for Healthcare Product Safety we hope to start clinical trials within the next two to three years - first in France and then abroad

Five French hospitals will participate in the clinical trials, including the Georges Pompidou European hospital where Carpentier is specialist in cardiac transplantation, and Pitié-Salpétrière in Paris.

If launched successfully, the prosthesis could prolong and improve quality of life for millions who have suffered major heart attacks or with serious heart disease and for whom standard drug therapy, ventricular assistance or a transplant have failed or are not possible.

While heart transplantation has a survival rate of more than 75% a year after the operation and 67% after five years, it is available to only a small proportion of patients. As well as medical and other reasons which make many patients unsuitable for transplants, there is an estimated lack of about 10,000 donors a year in Europe and 20,000 worldwide

A totally implantable artificial heart would provide a solution to them all, Carmat said.

jane.marshall@uw-news.com


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