French company Carmat has secured conditional approval from the US Food and Drug Administration (FDA) to initiate the second cohort of its early feasibility study (EFS) in the US with the Aeson artificial heart.
The EFS involves a total of ten eligible subjects for heart transplants.
Its primary endpoint is the survival of the patient at six months after implantation of the artificial heart or a successful transplant within this period.
The design of the study features two successive cohorts, with the first one with three subjects completed in the third quarter of 2021.
Following the initial cohort completion, the company made improvements to the artificial heart and submitted these changes to the US regulator.
The agency has reviewed and approved these modifications, allowing the company to commence recruitment for the second cohort, which will consist of seven subjects and includes an interim report on the initial three implants, stated the company.
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By GlobalDataCarmat is preparing to commence implants in the second half of this year, which involves securing approvals from ethics committees and updating the training of hospitals that are taking part.
Carmat CEO Stéphane Piat said: “The authorisation to initiate the second cohort of our EFS in the US, received from the FDA, marks a very important milestone in Carmat’s journey.
“It also represents a key step towards a potential commercial launch of Aeson in the US, which—subject to factors including the quality of our clinical results—could occur from 2028.”
Concurrently, the company plans to seek the US regulator’s approval for the latest version of Aeson, which is in use in Europe at present, to be utilised in the EFS study.
Carmat stated that its goal is to make Aeson, a first heart transplant option, addressing the shortage of available human grafts for individuals with end-stage biventricular heart failure.
The device is said to improve the quality of life and mobility for individuals, featuring an ergonomic and portable external power supply system connected to the implanted prosthesis.
In 2023, the company announced the first Aeson heart implantation in an individual with a cardiac tumour.
