France’s Carmat has won approval to proceed with the first human implantations of its artificial heart in four countries, the company said on Tuesday, sending its shares up 25 percent. The approval were given by the four international cardiac surgery centres in Belgium, Poland, Saudi Arabia and Slovenia, where the tests will be carried out, but not in France, where Carmat’s artificial heart is still to gain approval from the drug safety agency, ANSM. Among Carmat’s competitors are privately-held SynCardia Systems and Abiomed Inc., both of the US. The approval is “good news” that allows the French medical devices maker “to make progress on the subject of human implantation despite the growing demands of the ASNM,” Portzamparc analysts wrote in a note. The French regulator has asked Carmat to test the device on animals before it can allow implantation in humans. “The patient selection process and the training of the clinical teams are ongoing in these four countries (…) Implantations could start shortly following the completion of the training,” Carmat said. Developed by a team of engineers from Airbus parent company EADS, the Carmat devices mimic heart muscle contractions with two micro pumps, one for each ventricle or heart chamber.
