CARMAT’s artificial heart could potentially save thousands of patients without any risk of rejection. Credit: CARMAT.

French biomedical company Carmat, designer of the world’s most advanced total artificial heart project, has received approval to enrol patients for the second stage of the PIVOTAL study in Denmark.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

Tick here to opt out of curated industry news, reports, and event updates from Medical Device Network.

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.