This artificial heart is intended for people suffering from end-stage biventricular heart failure.
- The cost of the artificial heart is around 150,000 euros.
- Tests of the Carmat artificial heart have been carried out in France, the Czech Republic, Denmark and Kazakhstan.
- Heart failure is the cause of one death every seven minutes in France.
The artificial heart of the Carmat company has reached a new milestone: the first implantation, outside of a clinical study, was carried out by Italian surgeons. “This establishment marks the first sale made by CARMAT since its creation in 2008, explains the company in a communicatedpublished Monday, July 19. This is a major step, which opens a new page in the development of the company.“Carried out by the team of Dr. Ciro Maiello, cardiac surgeon at the Naples Hospital Center, the operation took place without any particular difficulty.”The patient is recovering well and with the combination of key features of the device – pulsatility, hemocompatibility and autoregulation – we believe he will benefit from a rapid transition to outpatient care.“, said Prof. Marosa De Feo, director of the Department of General Cardiac Surgery and Transplantation at the Azienda Ospedaliera dei Colli Hospital Center in Naples. The first implantation in the context of a clinical study was carried out in 2013, then it was followed by several other trials in different countries.
Milestones passed in recent years
The artificial heart, created by Alain Carpentier, is total: this means that it replaces the whole of the cardiac organ. The objective is to delay or even replace heart transplantation, made complicated by the shortage of grafts. According to the French Federation of Cardiology, today there are half as many grafts as there are patients.
In 2019, the Carmat company published the results of its PIVOT study, started in 2016. “70% of patients in this 1time cohort achieved the primary study endpoint of 6 months survival with the prosthesis or successful heart transplantation within 6 months of device implantation“, announced a communicated. In December 2020, the artificial heart, marketed under the Aeson brand, took a new step: it obtained CE marking. This allows the company to market it in all countries that recognize this certification.
A study in progress in the United States
On July 15, Carmat’s artificial heart was implanted for the first time in a patient living in the United States. This operation will be followed by several others, as it is part of a clinical trial in which one of the main evaluation criteria is the survival of the patient 180 days after implantation. “Three other US centers are fully trained and are currently selecting patients for the study.”specifies Carmat in a communicated. The development and marketing of the artificial heart across the Atlantic is conditional on the success of these trials. In Europe, five German hospitals are currently seeking patients for future implants. Carmat believes “that a dozen centers will be formed and commercially active by the end of 2021, mainly in Germany.”
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