Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure.

The artificial heart provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated. It is designed for patients expected to receive a heart transplant within 180 days.

“The CE marking is great news for patients and a major milestone for Carmat,” said Stéphane Piat, CEO of the Vélizy-Villacoublay, France-based company. “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.”

Heart failure affects at least 26 million people worldwide, about 5% of whom have end-stage disease that does not respond to current medical treatments. Fewer than half of individuals diagnosed with heart failure survive five years. While heart transplantation is the gold standard treatment for biventricular end-stage heat failure, an acute lack of donors limits transplants to about 5,500 per year.

U.S. feasibility study prepares for launch

Carmat anticipates launching its feasibility study in the U.S. shortly and completing enrollment of 10 patients by the end of 2021.

“As we intend to use a new version of the Carmat system, including features that enhance patient safety and quality of life, we had to submit amendments to complete our initial approved dossier in February 2020,” said Piat. “Based on ongoing discussions with the FDA, we expect to treat the first patients in the U.S. with the new prosthesis in first quarter 2021.”

In dialogue with the FDA, Carmat has submitted nine amendments to enable use of its commercial configuration of the device in the study. As of late November, eight of the amendments had been approved. The Centers for Medicare and Medicaid Services approved the device for reimbursement in May.

Three centers in the U.S. are currently involved in preparation for the feasibility study. They include the University of Pittsburgh McGowan Institute for Regenerative Medicine Preclinical Studies Center, Virginia Commonwealth University’s Pauley Heart Center, the University of Louisville Jewish Hospital, and the Baylor University Medical Center in Dallas.

“Despite the COVID-19 pandemic, we were able to train the first three American centers selected for our feasibility study,” Piat added. “They all came out of this experience very enthusiastic and committed to the success of this study.”

The company also received approval to proceed with a prospective, multicenter, nonrandomized clinical study of the device in France. The EFICAS study will include 52 patients who will receive the device as a bridge-to-heart transplantation. The primary endpoint will be survival rate at 180 days without disabling stroke or successful heart transplant within 180 days. The 52 patients receiving the Carmat device also will be compared to a control group that will receive usual transplant bridge therapies for a cost-effectiveness analysis.

In October, Carmat received €13 million ($11.8 million) in funding for the EFICAS study from the French Ministry des Solidarités et de la Santé that the company expects to cover about two-thirds of the cost of the study. “This financing facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021,” Piat told BioWorld.

Device restores circulation, enables mobility

The technology underlying the company’s total heart arose from the combination of the expertise of cardiac surgeon Alain Carpentier, who pioneered mitral valve repair and invented the Carpentier-Edwards heart valves, and the technological capabilities of the aerospace company Matra Défense (Airbus Group).

Carmat’s electro-hydraulic system mimics the action of a human heart, restoring normal blood circulation throughout the body.

The system includes an implantable component shaped like a human heart. The bioprosthetic heart includes four biological valves that keep blood pulsing through the unit in one direction, two ventricular cavities separated by a membrane, a motor pump unit, and integrated electronics and sensors that enable the unit to respond to the patient’s physiological needs. One ventricular cavity contains blood, and the other holds actuation fluid. An outer bag also contains actuation liquid.

Portable external equipment includes a controller and lithium-ion batteries that provide four hours of mobility. A hospital-based console gives physicians control of the heart prosthesis during implantation and enables monitoring of the device.