A total artificial heart (TAH) has been greenlit for sales in the European Union after approval for use in patients who desperately need a transplant, but are suffering from the ongoing donor shortage. The approval allows the heart manufacturer, CARMAT, to roll out its device that directly mimics a biological heart to EU hospitals. 

While the TAH is a fully functioning heart device, it is mainly used to bridge the gap between patients that are suffering end-stage heart failure and require a transplant in the next 180 days but do not have immediate access to a matched donor. The heart comes with an outer console operated by medical staff whilst it is transplanted, but the recipient can return home and live a near-normal life with the prosthesis in place. 

“The CE Marking is great news for patients and a major milestone for CARMAT. As early as January, we will accelerate the ramp-up of our manufacturing activities and intensify discussions with our core target customers in order to achieve a  smooth commercial launch during the second quarter of 2021, and thus offer a solution to many patients waiting for a heart transplant,” said Stéphane Piat, chief executive officer of CARMAT, in a statement. 

Consisting of four biological valves, two ventricles, and two micro-pumps that push blood throughout the body to replace the action of a natural heart. It runs autonomously and has an expected battery life of around 4 hours, enabling the patient to do far more than previously possible. 

The implications of a widespread mechanical heart are huge, with 26 million people worldwide affected by heart failure. Despite the desperate need for donors, a poor supply of transplant hearts limits the number of surgeries to just 5,400 per year worldwide. CARMAT hopes that a supply of approved artificial hearts will alleviate the shortage, both improving survival rates for those at end-stage heart failure and improving quality of life for those waiting for a transplant.  

The TAH has been involved in clinical trials over the past few years with the view for approval, with the first implantation occurring in May 2020. A PIVOTAL trial, which is typically a Phase 3 trial, is still underway and actively recruiting participants to confirm the safety and efficacy of the heart, which aims to end in December 2021. Prior studies suggest the TAH is safe and had very few alternative health effects on the patient, although the samples were limited.

“With its hemocompatibility, autoregulation, and silent operation, the CARMAT TAH could become a real alternative treatment to heart transplantation for patients suffering from end-stage heart failure,” said Finn Gustafsson, principal investigator for the study, in a statement.