Carmat’s Total Artificial Heart Gains European Clearance
Carmat has received CE mark certification for its total artificial heart system, allowing its use in Europe for certain patients with heart failure.
The certification clears the device for use as a bridge to heart transplant in patients suffering from end-stage biventricular heart failure. The system may now be used in patients who cannot tolerate the highest doses of medical therapies or a left ventricular-assist device and who are likely to undergo heart transplant within 180 days after implantation.
France-based Carmat said it plans to launch the product commercially in the second quarter of 2021, noting that the device will fill an unmet medical need for people suffering from end-stage biventricular heart failure.