Artificial Carmat hearts will begin to be marketed in the second quarter, after obtaining its European certification. “We are aware of our limits so that we will focus on Germany and we will work on France,” Stéphane Piat, CEO of Carmat.
The commercialization of the Carmat artificial heart, designed by Professor Alain Carpentier, will begin in the next quarter. After years of clinical trials and improvements, the French company that developed this heart obtained European European certification at the end of December.
The first implantation took place on December 12, 2013. Claude Dany, the patient, had survived two and a half months and paved the way for this technology. The Carmat artificial heart is marketed even before clinical trials are completed. Seven patients still need to be implanted to complete the pivotal study.
Germany : The Number One Target
The artificial heart will be marketed “in the European community countries and in a dozen countries that accept the CE marking, such as Russia, Kazakhstan”, detailed Stéphane Piat, CEO of Carmat. “We are aware of our limits, so we will focus on Germany, which represents more than 40% of the mechanical assistance technology market, and we will work on France which means 15% of the market through the efficient clinical study. With two countries we will be able to cover almost 60% of the European market.”
Designing such a heart takes more than a year, explains the leader. “For an electronic board, it takes a year from ordering the components to assembly and supply to Carmat. In general, once you have all the parts, it takes two and a half, three months for the product is finished, sterile and ready to be sent to the hospital. Our goal is to get to ten a month fairly quickly. It does not seem like much from the outside, adds Stéphane Piat, but we do not use as many artificial hearts or mechanical assistance systems as stents, and the price is not the same.”
This artificial heart costs around 150,000 euros. The question is also to know what will be the coverage of Social Security. Carmat plans to manufacture about 300 artificial hearts per year within three years at its factory in Vélizy (Yvelines).
Heart for Patients at the End of their Life
The Carmat heart is still far from lastingly prolonging the lives of patients. In clinical trials, only one patient has survived for more than two years, while a conventional transplant can expect to live almost 20 years longer. This heart is intended for patients “who suffer from the bi-ventricular disease, it is when the heart no longer pumps, and the ventricles swell and prevent the heart from functioning normally”, explains Stéphane Piat.
Very few people die of infarction since we have stents, according to Stéphane Piat, but we have created, he says, “a population of very fragile patients”. “Implanting a heart will be more profitable than not treating a patient,” he defends. In particular, it allows holding until a natural graft is free, or there is a shortage of genuine hearts. Around 500 heart transplants are performed each year, while more than 10,000 French people are awaiting a transplant.
As for the question of knowing if we will be able to change hearts as quickly as clothes, Stéphane Piat says he believes it. “When I see where we started and where we can get with technology. In 1957, the pacemaker was a big box on the outside of the body with two cables. Now it’s a euro coin. I think that in 10 to 15 years the artificial heart or similar technology will be completely locked in the thorax. Today, our positive displacement pumps have no wear for ten years. There will be a technology that we can use.” he says.