Carmat, the company working to create the world’s most advanced total artificial heart to treat biventricular heart failure, has successfully implanted the device in a tenth patient, completing the first part of the PIVOTAL study.
The completion of patient enrolment at this stage is in line with the company’s objective of obtaining a CE mark for the artificial heart in 2019.
Carmat CEO Stéphane Piat said: “This marks the end of the first leg of the study and will allow us to start the second leg right away. The second part of the study includes ten additional patients which we believe should be enough to file for CE marking.
“Thanks to the knowledge accumulated in treating the first ten patients we are confident to further improve patient outcome in the next cohort. In order to support us in this mission, I am proud to announce that Professor Ivan Netuka, professor of cardiac surgery and chairman of the Department of Cardiovascular Surgery at IKEM in Prague, has accepted to be the principal investigator of the second leg of the study and that Professor Finn Gustafsson, professor of cardiology at Rigshospitalet hospital in Copenhagen, will support him as co-principal investigator.
“Naturally, Professor Christian Latrémouille, professor of cardiac surgery and chairman of the Department of Cardiac Surgery at the European Hospital Georges-Pompidou in Paris, will continue to support us with his invaluable experience of the Carmat heart implantations. With the three international centres already active and those that should join shortly, we confirm our objective to reach 20 implanted patients by year-end.”
Co-principal investigator Gustafsson added: “Advanced heart failure is a fast growing disease for which there are limited treatment options available today and I am excited to be involved in this project that might change the way we treat our patients in the future.”
The study, authorised in France, Kazakhstan, the Czech Republic and Denmark, is necessary to compile the company’s CE marking clinical dossier. During the study, Carmat plans to implant its device in approximately 20 patients with end-stage biventricular heart failure. The primary endpoint for the study is patients surviving with a Carmat device for 180 days post implant or survival to cardiac transplantation if this occurs before 180 days post-implant.
So far, the success of surgical procedures has been 100%, which Carmat suggests highlights the strong expertise of the surgical teams in the participating centres.
In order to maintain the sustained implantation rate, Carmat aims to expand the network of investigating centres to new countries and plans to finalise the PIVOTAL study implantations by the end of 2018.