French Artificial Heart Company Has First-in-Man Implant

CARMAT has completed the first-in-man implantation of its bioprosthetic artificial heart. The procedure was performed on December 18 at the Georges Pompidou European Hospital in Paris, France. The company is developing a total artificial heart to provide an alternative for people suffering from end-stage heart failure.

The implantation was part of a feasibility study conducted with approvals granted by the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé, the French health authority) and the Comité de Protection des Personnes (French healthcare ethics committee).

Company officials report that the implantation went smoothly, with the prosthesis automatically providing blood flow at physiologic conditions. The patient is currently being monitored in the intensive care unit. He is awake and communicative

“We are delighted with this first implant, although it is premature to draw conclusions given that a single implant has been performed and that we are in the early postoperative phase,” said Marcello Conviti, CEO of CARMAT.

According to the company, chronic and acute heart failure affect more than 100 million patients in developed countries. The treatment of heart failure is mostly palliative: drugs, cardiovascular rehabilitation, multi-site pacing, conventional surgical revascularisation, mitral annuloplasty and mechanical circulatory assistance techniques, etc.

The only treatment for patients with advanced bi-ventricular heart failure who do not respond to any of these possibilities is cardiac transplantation. However, fewer than 4,000 donor hearts are available each year throughout the world compared to more than 100,000 patients waiting for a solution.

CARMAT’s technology is being developed with expertise from Alain Carpentier, M.D., Ph.D., a French surgeon and inventor of the Carpentier-Edwards heart valves who is considered by many to be the father of modern mitral valve repair, and European aerospace giant EADS.

“The artificial heart is functioning normally, automatically catering to the body’s needs without any manual adjustment necessary,” surgeons Alain Carpentier and Christian Latremouille said in a statement issued by the hospital.

Three more patients in France are due to be fitted with the device. In this first series of clinical studies, its success will be judged on whether patients survive with the implant for at least a month.

The people selected suffer from terminal heart failure – when the sick heart can no longer pump enough blood to sustain the body – and would otherwise have only a few days or weeks to live.