A male patient has just undergone successful heart transplant surgery five months after receiving a Carmat artificial heart. Surgery was performed at the National Research Center of Cardiac Surgery in Astana, Kazakhstan. This is the second patient to undergo this type of procedure. The first Astana patient received a Carmat artificial heart in October 2017, and had not been eligible for heart transplant surgery because of his high blood pressure. In the eight months since receiving the artificial heart, the transplant patient’s condition stabilised and transplant surgery could eventually be performed. “This world first shows that the Carmat artificial heart is also suitable for patients presenting co-morbidities which prevent transplantation in the first instance,” explains Stéphane Piat, CEO of Carmat, even though “its primary purpose is to offer a permanent therapeutic alternative given the lack of transplant organs”.
The French company is currently carrying out a European pivotal study to “get the green light to sell the product in Europe (CE marking) in 2019″. Among the first 11 patients to receive a Carmat heart, the one month survival rate is 91%: one patient died after a few weeks from an infection which, according to the company, was not linked to the prosthesis. “We have switched to the second part of the study with the eleventh patient who has just undergone transplant surgery”, explains Stéphane Piat. “My aim is to complete the study by the end of the year, as planned. However, to maximise our chances of success, caution must still be exercised in selecting the last nine patients”. The six-month survival of twenty patients will be crucial for European certification.
Two other countries are currently involved in the clinical study, namely the Czech Republic with IKEM, in Prague and Denmark with Rigshospitalet,in Copenhagen. “We are in very advanced discussions with the FDA and hope to be granted authorisation to start a feasibility study in the US between now and the end of this year,” adds the CEO.
Les Echos, Chantal Houzelle (28/09/2018)
AFP (28/09/2018)