The World | 21/12/2013 at 10:50 • Updated 22/12/2013 at 15:20 | By Sandrine Cabut
We learned Friday that the first implantation in humans of the fully implantable cardiac bioprosthesis CARMAT was made two days earlier at the European Georges Pompidou Hospital (AP-HP, Paris) by Professor Christian Latrémouille , cardiovascular surgeon at this, and Professor Daniel Duveau (CHU Nantes). The patient operated, aged 75, suffered heart failure had reached a terminal stage -. Threatening its short-term prognosis
“This first settlement took place satisfactorily, the prosthesis automatically ensuring normal circulation at physiological flow. The patient is under observation in intensive care, awake and interacting with his family, “ said Carmat Friday, Dec. 20 in a statement released just after the close of trading. For this medical breakthrough is also a financial venture for the company Carmat, created in 2008.
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“We welcome this first implementation, but it would of course be premature to draw conclusions because it is a single location and even post-surgical very short time” found Marcello Conviti CEO Carmat, in the same statement.
Pompidou hospital, with Marie-Lannelongue surgical center of Plessis-Robinson (Hauts-de-Seine) and the University Hospital of Nantes, one of the three sites selected for this first clinical trial. Initially, no communication was provided for this ultra-early stage. The secret was to be kept until the four patients included in the protocol were made. But the schedule was disrupted by a leak event almost inevitable in such a sensitive.AN AMBITIOUS PROJECT
For over fifty years, the challenge of an artificial heart, an alternative to heart transplantation for patients with terminal heart failure, mobilized many teams in the world. Several generations of heart pumps have faced many obstacles: mechanical failure, blood clots in the prosthesis to cause thromboembolic … So many life-threatening complications
ventricular assist devices have been approved, and are mainly used in waiting for a heart transplant. But their performance and size are far from satisfactory.
worn by the surgeon Alain Carpentier since the 1980s is much more ambitious project. The goal is a fully implantable bioprosthesis mimicking the natural heart, with its adaptation to stress. Already famous for inventing biological valves (from animal tissue) that prevent clotting problems metal valves and thus dispense with anticoagulants, Professor Carpentier takes this approach to the center of attention? Artificial heart.
In 1993, he joined forces with Jean-Luc Lagardère, CEO of Matra (now a subsidiary of EADS), attracted by the challenge. A first prototype was developed in 2000, it weighs 1900 grams, which is 6-8 times more than a normal adult heart. Gradually, the volume, weight and power consumption are optimized. Carmat the heart is implanted in calves. The current prototype weighs about 900 grams, which, according to its creators, making it compatible with 70% of the chest of a man, and a quarter of female thorax.
green light of an ethics committee for a first implantation in humans is obtained in France in late 2011, but not much … not move until May Carmat then makes sensation by announcing obtaining permission to test its bioprosthesis in Saudi Arabia, Slovenia, Poland and Belgium.
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stock price jumps, but the strategy is surprising. Why not make the first tests in France, where this jewel of technology and research has been developed? The situation is all the more surprising that contacts are made since 2004 with Medicines Agency (AFSSAPS become MSNA), which provides clinical trial authorizations, and that French surgical teams are involved in the project.
MSNA was not at this date not yet given the green light, saying “folder items were not sufficient to assess the security of patients’ The specter of … relocation of the first tests of the French heart has he played, or new elements reassuring Were provided by Carmat? The Medicines Agency has finally granted permission in September.
Friday night, the Health Minister Marisol Touraine welcomed in this world premiere “great pride for France” .
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bet is still far from won. The artificial heart must now prove that it is well tolerated and may improve the prognosis of patients.
For this first study said feasibility “success will be evaluated by including survival rates one month” , showed the firm in September.
Patients Are their side ready to try the adventure of a biomechanical heart? “Many heart transplant imagine an artificial body would be easier to manage psychologically a human heart, because it does not rely on the transplantation of someone’s death. But it will undoubtedly raise many more questions, “ says Julien Biaudet, who conducted a survey of heart transplant as part of his sociology thesis, defended in November.