A joyeux Noël for Carmat

When the French medtech Carmat told Evaluate Vantage in summer 2019 that it would submit an EU marketing application for its artificial heart by the end of 2020 the schedule looked rather ambitious. In fact the company was being unnecessarily humble: yesterday saw not a submission for the device but CE marking itself. The artificial heart may now be used as a bridge to transplant – keeping patients alive until a donor heart becomes available – in patients suffering from end-stage biventricular heart failure who cannot be treated with medical therapy or a left ventricular heart device, and who are likely to undergo heart transplant within six months of implantation. The achievement is all the more remarkable considering the fact that the European pivotal trial is still ongoing. Success in the first cohort of 10 patients was reported two years ago, but the second cohort will not yield data until next year. The lack of donor hearts is so pressing a problem that EU approval has been awarded on the basis of the device's showing in the first cohort. Launch will begin in the second quarter of 2021.