Denmark is the third country after Kazakhstan and the Czech Republic, where the company has received the required authorisation for Phase I of the PIVOTAL study.
After the company made changes at prosthesis manufacturing process level, it had to resubmit the clinical trial for reauthorisation in all three countries. Denmark was the first country to approve.
Carmat will continue the study with the new prostheses exclusively produced on the Bois-d’Arcy site.
The implants will be complete at the Rigshospitalet’s Department of Cardiology in Copenhagen according to the requirements stated by the ethical committee.
Carmat CEO Stéphane Piat says: “This approval in Denmark allows us to be in line with our roadmap. I firmly believe that the teams headed by Prof Finn Gustafsson, Co-Principal Investigator for the second part of the PIVOTAL study, will put all of their expertise into serving the first Danish patients who will receive our new prosthesis.
“Given its sturdiness and the recent positive autoregulation results, we are confident that we can meet the requirements of patients awaiting a heart transplant and those who are not eligible for a transplant.”
Piat further added that the company is in discussions with the authorities in the Czech Republic and Kazakhstan to finalise the enrolment of the second patient cohort in the PIVOTAL study.
The company also plans to submit the reports from the trial to the Dekra certification body to attain CE marking by next year.
In July last year, Carmat successfully implanted the device in a tenth patient, completing the first part of the PIVOTAL study.