France Approves New Artificial Heart for Human Trials

The French Health Authority ANSM has approved for human trials a new artificial heart made by French medtech company Carmat S.A. Carmat enlisted the help of Astrium, the world's second-largest aerospace firm, for the ultrahigh precision and durability necessary for the project.

The artificial heart is constructed using both manmade and biological materials and is designed to last five years. Each of the 900 components must function flawlessly and has been the subject of exhaustive computer and test bench evaluation.

The Phase 1 trial approved by the ANSM is a feasibility study on four patients. Its success will be assessed particularly by the 1-month survival rate or the patient's bridging to transplantation if he or she is eligible.

Marcello Conviti, Carmat's CEO, said in a press release: "I would like to thank the ANSM, with which we have had very rewarding interactions, the clinicians involved in preparing the study and our shareholders, whose patience and support have been rewarded. We are touched and eager to be able to propose replacing a patient's sick heart with a CARMAT heart."

In an interview with Reuters, Conviti said that the company hopes to finish human trials by the end of next year and to obtain regulatory approval for an EU launch by early 2015. The firm is also seeking a partner in the United States to enter the world's largest healthcare market, and, according to Conviti, is in contact with Johnson & Johnson, Medtronic, St Jude Medical and Edwards Lifesciences,

The Carmat device weighs about 900 g and mimics natural heart muscle contractions. It contains sensors that adapt the blood flow to patient movements. Power comes from external wearable lithium-ion batteries. Inside the heart, blood-contacting surfaces are partially made from bovine tissues to reduce the risk of blood clots.

The sheer size of the artificial heart means it can fit 86% of men but only around 20% of women. However, Conviti has stated that a smaller version that would fit smaller bodies will be feasible.