French company Carmat has won approval to proceed with the first human implantations of its artificial heart in four countries, sending its shares up 25 percent. The approval were given by the four international cardiac surgery centers 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 United States.
“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 in a press release.
Developed by a team of engineers from Airbus parent company EADS, the Carmat devices – expected to cost 150,000 euros ($193,600) each - mimic heart muscle contractions with two micro pumps, one for each ventricle or heart chamber. The device moves blood to the lungs and into the body. The new design uses cutting-edge biopolymer materials that promise to reduce the formation of dangerous blood clots—a persistent problem with early artificial hearts—and may even spare patients from needing to use nettlesome anticoagulant drugs. Around 5.7 million people in the U.S. have heart failure at any given time, according to the Centers for Disease Control and Prevention. In these patients, the heart’s pumping abilities have grown so weak that it cannot deliver enough oxygen and nutrients to the body.