French medical technology company, Carmat, has been granted a CE mark for its artificial heart system. The fully implantable artificial heart offers a therapeutic alternative to patients suffering from end-stage biventricular heart failure.

It took 10 years for Carmat to obtain the CE mark. “It’s a record, given the complexity of such a device,” said Carmat Chief Executive Officer Stephane Piat “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. But this represents great news for patients and a major milestone for Carmat.”

The company is now ramping up its production with the aim of launching the device across Europe in the second quarter of 2021.

Carmat’s artificial heart system is targeted at individuals who have suffered a heart attack but are not benefitting or unable to undertake standard drug therapy and/or ventricular assistance. It is designed for patients expected to receive a heart transplant within 180 days.

Heart failure affects at least 26 million people worldwide and an estimated 5% are at end-stage where they aren’t responding to any medical treatment. Even though heart transplantation is regarded as the gold standard of treating biventricular end-stage heart failure, there are only about 5500 donors each year.

Renowned heart surgeon Alain Carpentier pitched the idea of creating an artificial heart to French industrialist Jean-Luc Lagardere in 1993, who then set aside laboratory and engineers from his Matra missile company to help Carpentier. The project continued to grow even during the period when Matra merged and became a part of Airbus SE. Carmat was officially incepted in 2008, with the plane-maker remaining its biggest shareholder.

Last February, Carmat received full approval from the FDA to conduct a clinical feasibility test of its artificial heart system in the US and subsequently, CMS reimbursement in May.

In October, the French Ministry des Solidarités et de la Santé helped fund a clinical study where 52 patients received the Carmat device as a bridge to heart transplantation.

Carmat now expects the first artificial heart implant to be performed in the first quarter of 2021 with the enrolment of 10 patients completed by the end of 2021.