The company Carmat recently performed an artificial heart implant for its tenth patient (see: Carmat prepares to market its artificial heart). According to a company press release, none of the study patients died during surgery or in the days following the procedure. However, some of them died shortly afterwards.
The second part of the Pivot study—led by professors Ivan Netuka, Director of the Department of Cardiovascular Surgery at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, and Finn Gustafsson, from Rigshospitalet in Copenhagen—focuses on ten additional patients, presenting terminal biventricular heart failure, like the first ten patients, and for whom no therapeutic alternative is available. The primary endpoint in this study is the six-month patient survival rate following implantation.
The twenty patients participating in the Pivot study are from France, Kazakhstan, Czech Republic and Denmark. Carmat wants to expand its network to new countries in the near future in order to “sustain the number of implantations carried out”. “We reiterate our goal to operate on 20 patients by the end of the year”, confirmed Stéphane Piat, Carmat’s CEO.
Furthermore, the CE marking process leading to certification from DEKRA is coming to an end. Validation is expected in 2019 with the latest results of the Pivot study.
For further reading:
Le Quotidien du Médecin, Damien Coulomb (12/07/2018) Cœur artificiel CARMAT : un 10e patient implanté