Denmark was the third country outside France where CARMAT had the necessary authorizations to conduct the first part of the PIVOTAL study
Image: The implants will be performed at the Rigshospitalet's Department of Cardiology in Copenhagen. Photo: Courtesy of CARMAT.
CARMAT, 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 announces the first approval to resume patient enrollment for the second part of the PIVOTAL study in Denmark.
With Kazakhstan and the Czech Republic, Denmark was the third country outside France where CARMAT had the necessary authorizations to conduct the first part of the PIVOTAL study. Following the changes implemented at prosthesis manufacturing process level, the Company was obliged to resubmit clinical trial authorization requests in these countries. The competent authorities in Denmark are the first to give CARMAT their approval to continue the clinical study with the new prostheses produced exclusively on the Bois-d’Arcy site. The implants will be performed at the Rigshospitalet’s Department of Cardiology in Copenhagen in accordance with the requirements of its ethical committee.
Stéphane Piat, Chief Executive Officer of CARMAT, says: “Following the production process changes successfully implemented and industrialized at the end of the first half of 2019, our aim was to resume implants within the framework of the PIVOTAL study by the end of the third quarter of 2019. 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. Furthermore, we are continuing our active discussions with the authorities and investigation centers in Kazakhstan and the Czech Republic in order to rapidly finalize the enrollment of the second patient cohort in the PIVOTAL study and submit the full clinical file to the DEKRA certification body with a view to obtaining CE marking in 2020”.
Source: Company Press Release