The Carmat company, which is developing a total artificial heart, announced on Tuesday that it had received the green light from the National Agency for the Safety of Medicines and Health Products (ANSM) to resume the implantation of its device in France.
Carmat had suspended in October 2018 its current "
pivot
"
clinical trial
in Europe as well as its production of prostheses due to data showing risks of their dysfunction.
Read also: Carmat's artificial heart resumes its tests in Europe
Following changes made to the prosthesis production system, Carmat then submitted clinical trial authorization applications in countries that had already given their authorization.
The number of implantations carried out is thirteen.
Most recently, the company announced in May that its prosthesis would be implanted in Denmark, the third country to enter the study, along with the Czech Republic and Kazakhstan.
This green light will allow French hospitals to finalize the recruitment of patients for the "
pivotal
"
study
by the end of the first quarter of 2021, the statement said.
"
The pace of recruitments, affected by the Covid-19 situation in centers in the Czech Republic, Denmark and Kazakhstan, could thus accelerate with the participation of highly specialized French centers to complete this key study
," said Stéphane Piat. , CEO of Carmat, quoted in the press release.
To read also: Carmat artificial heart: first establishment in Denmark
The artificial heart developed by Carmat aims to offer an alternative option to heart transplantation for patients suffering from end-stage heart failure.
