While everybody’s busy “exchanging hearts” last Valentine’s Day, an appalling announcement was released by the CEO of Carmat, Mr. Stéphane Piat- he unveiled the unfortunate death of a patient, whose artificial heart was implanted last 26th
of August, 2016.
However, this was believed to be a “human error”. A 68 years old man died in his hospital room after he manipulated the batteries of his artificial heart. This was exactly forty-seven days after the operation. Further, although trained in its use, the patient took initiative to change only the batteries and made a handling error of not taking precautions in putting the prosthesis. Despite the alarm system, this caused his ‘new’ heart to stop functioning and hence, without power, led to his decease.
Moreover, this isn’t the first incident wherein a patient with artificial heart died. This fifth passing led Agence française de sécurité sanitaire des produits de santé (ANSM), France’s national drugs agency, to order Carmat to suspend further implants. This caused Piat's frustration on which he explicitly said, "In France, innovation like the Carmat heart gets blocked, while it should be the fruit of strong collaboration between the authorities, the company, specialists, patients ... We are not on the same wavelength."
Due to this, Carmat approached the US Food and Drug Administration (FDA) for possible trials and faster feasibility study to be conducted. Carmat is actually hoping to complete its tests in 2018 and obtain a CE marking in order to sell its first prostheses in Europe by 2019, and in United States by 2020. This start-up has previously received a lot of money through fundraising but has lost around a quarter of their value since the announcement of the first implantation. A capital increase, nonetheless, would be needed if industrialization comes to reality.
Despite these controversial deaths, Piat is still optimistic, stating that such prosthetic has still acquired a value in "[showing] that the concept of an artificial heart can work". This device could still represent a major medical breakthrough if proven reliable.