France-based Carmat SA will start selling the first-ever total artificial heart this year, Bloomberg news agency reported last week.
According to the report, Carmat last week obtained a CE mark for the device, meaning the company can now sell it in the European Union as a bridge to a heart transplant for patients suffering from irreversible end-stage heart failure.
It took 10 years for Carmat to obtain the CE mark, and “it’s a record, given the complexity of such a device,” Carmat Chief Executive Officer Stephane Piat said. “We’ll have to work with doctors and medical centers now to offer our therapy and we’ll have to look for patients.
The production phase will be a delicate one.”
Carmat’s artificial heart has blockbuster potential and could reap 700 million euros in annual sales in Europe by 2030, according to the Portzamparc analyst Mohamed Kaabouni.
Carmat will start selling the device in the second quarter of 2021.