The French company Carmat announced a few days ago that it has received permission to resume its clinical studies on artificial heart.
The clinical trials on this device had been suspended in France following the death of a patient. Carmat has now been allowed to begin new clinical trials for this device in France, seven years following their first attempt.
Indeed, the French National Authority for Health (“HAS”) and the National Agency for the Safety of Medicines and Health Products (“ANSM”) have declared the Carmat artificial heart eligible for the “Innovation” program, which facilitates the study and eventual marketing of selected innovative medical devices. “HAS” believes that “the Carmat heart meets the selection criteria for innovation due to its use of biological materials in contact with blood, its self-regulating capacity and the lighter and quieter external equipment”.
Carmat’s Managing Director Stéphane Piat said: “We are delighted by the “HAS” decision, which demonstrates that safer and more effective patient management of heart failure in France is truly necessary. Following the recent approval by the FDA (Food & Drug Administration) to launch feasibility studies for our device in the United States, this is an important step forward to make our technology available for eligible heart transplant patients as soon as possible.”
Indeed, on February 5 Carmat received FDA approval for launching a clinical trial on 10 patients in the US, where the company has already obtained conditional approval from two American ethics committees.
Since there is a severe shortage of hearts for transplants, this artificial heart is promising for increasing the life expectancy of patients with severe heart failure who are awaiting transplantation.