CARMAT granted authorization to resume the PIVOTAL study in Kazakhstan
- The Company has received the approval of the Kazakhstan health authority and the ethics committee of the National Research Center for Cardiac Surgery in Nur-Sultan, which has substantial experience with the CARMAT device
- The study can now be conducted simultaneously in 3 countries
Paris, December 2, 2019 – 7.00 am CET
CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced that it has received authorization to resume the PIVOTAL study in Kazakhstan.
The implants will be performed at the National Research Center for Cardiac Surgery in Nur-Sultan (formerly called Astana), where the teams, led by Professor Yuri Pya, have successfully implanted the CARMAT device during the first part of the PIVOTAL study. Furthermore, several bridge-to-transplant surgeries conducted in this center demonstrated the ability of its surgical teams to successfully manage the explant procedure of the device as a donor heart becomes available. With authorizations in Kazakhstan, the Czech Republic and Denmark, the Company aims to complete enrollment of the second cohort of patients in the PIVOTAL study in order to obtain CE marking in 2020.
Stéphane Piat, Chief Executive Officer of CARMAT, said: “We are pleased to announce that we have been given the approval to enroll new patients in Kazakhstan. Together with the teams in Nur-Sultan, we are actively preparing for upcoming implants. With this approval, we reach our objective to resume the study at a center experienced both with device implantation and explant for transplant-eligible patients.”