FDA approves Carment artificial heart for early feasibility study

FDA approves Carment artificial heart for early feasibility study.   FDA approves Carment’s latest generation artificial heart for early feasibility study in the United States.

The device uses highly biocompatible materials to provide a unique self-regulating system, and its pulsation characteristics are expected to reduce or eliminate the risk of rejection in patients.

February 10, 2021-The US FDA approved the artificial heart developer Carmat to use its latest generation artificial heart in the US for an early feasibility study (EFS). This latest generation of artificial heart is a further improvement of artificial prosthesis and wearable system based on the clinical experience obtained in the PIVOTAL Study.

The company believes that this latest device will further improve patient safety and quality of life. Carmat is committed to providing treatment alternatives to heart transplantation for patients with end-stage biventricular heart failure.

The company said it expects EFS to enter the group for the first time in the first quarter of 2021. Carmat was approved by the Center for Medical Insurance and Medicaid Services (CMS) in May 2020 for device reimbursement and related services within the framework of this research.

Stéphane Piat, CEO of Carmat, said: “It is a pleasure to provide the latest generation of artificial heart to research centers in the United States, which is similar to our existing CE products.

Despite the emergence of COVID-19, we were able to train and launch three of these centers by the end of 2020, and these centers are now ready to start enrolling patients. It also intends to continue training and open more selected centers. “

The Carmat total artificial heart consists of an implantable biological valve and its portable external power supply system. The artificial heart overcomes the shortage of heart transplantation needed for thousands of people with irreversible end-stage heart failure, which is the most severely affected among the 20 million patients with this disease in Europe and the United States.

The product is the result of two unique experts in the field. One is Professor Alain Carpentier, who is famous for his invention of the most used Carpentier-Edwards heart valve in the world; the other is the world’s aerospace leader Airbus Group Technical experts.

The device uses highly biocompatible materials to provide a unique self-regulating system, and its pulsation characteristics are expected to reduce or eliminate the risk of rejection in patients.

(source:internet, reference only)

Disclaimer of medicaltrend.org