Artificial Heart Implant is the First of its Kind in the U.S.

Key Takeaways

Matthew Moore of North Carolina is now the first U.S. patient with a Carmat total artificial heart.

On Monday, July 12, surgeons Jacob Schroder, MD, and Carmelo Milano, MD, successfully implanted the device in Moore, who had been living with complications of serious heart failure for about a month. The artificial heart will keep Moore healthy as he awaits a true heart transplant within the next three to four months.

“Despite our efforts with heart transplantation and pumps—which just replace the left ventricle—many of these patients don’t have a treatment option, so we’re very happy to engage with the Carmat company and with their product,” Milano said in a press conference.

Clinical Trial of a Promising Shorter-Term Solution

The Aeson device is meant to help those withbiventricular heart failure, where both the right and left sides of the heart no longer pump blood throughout the body as they should. Aeson is implanted in the body to provide short-term treatment before a patient can receive a heart transplant — termed a bridge to transplantation.But that can often take months, as demand for heart transplants usually outpaces supply. Carmat says researchers are testing Aeson for up to 180 days of use—or six months—which would hopefully give heart failure patients the extra time they need to find an available transplant.

How to Get on the Waiting List for an Organ Transplant

The Food and Drug Administration (FDA) approved Carmat to begin testing its newest version of Aeson in U.S. patients back in Februaryas part of an Early Feasibility Study, which typically enrolls a small number of patients to learn more about a device’s safety and functionality.This procedure at Duke University Hospital is the first of what will likely be 10 Aeson implant surgeries for patients with biventricular heart failure.

The first three patients will be monitored for 60 days after their surgeries, and if all is well, then the other seven patients will get the implant, according to Carmat. The clinical trial is just meant to test how the devices function in the short term for patients waiting for heart transplants, but Schroder said in a press conference that patients could potentially use it for years at a time in the future.

The French government also gave the company fundingto conduct a 52-person clinical study of Aeson in France that began in 2020. Aeson is commercially available in Europe, according to the company’s website.

How it Works

Aeson works a bit differently—it automatically adjusts the rate at which blood is pumped throughout the body as needed, and also has a bovine biological lining that prevents potential blood clots and strokes, Milano explained in a press conference.

A Step Forward in Addressing the U.S.’s Heart Disease Epidemic

Since Moore was the first U.S. patient to receive the Carmat artificial heart implant, he will be monitored for any complications. Besides the fact that the device is large and can only be used on larger patients, Milano said, the Duke team is hopeful that Aeson can be used in other biventricular heart failure patients.

“As wonderful as heart transplantation is, we’re only getting three or 4,000 patients out of the 100,000 patients who have this terrible terminal condition. So, there is a huge opportunity for additional therapies for this group of patients, and we hope that the Carmat is one of the potential therapies that can help the other 96,000 patients out there,” Milano said.

Everything You Need to Know About Getting a Heart Transplant

A Word From Our Medical Expert Board

“This is an exciting new development, one that we all hope will advance the bridge-to-transplantation technology and maybe even destination therapy. But it’s also important to keep in mind that this implant was just the first in a pilot study. Aeson has been approved in Europe, and is now being evaluated in the U.S. in up to 10 patients as a bridge to transplantation. So we need to follow along and see how the device performs according to the trial protocol.”

Yasmine S. Ali, MD, MSCICardiologistYasmine Ali, MD, is board-certified in cardiology. She is an assistant clinical professor of medicine at Vanderbilt University School of Medicine and an award-winning physician writer.Read more

Yasmine S. Ali, MD, MSCICardiologist

Yasmine S. Ali, MD, MSCI

Cardiologist

Yasmine Ali, MD, is board-certified in cardiology. She is an assistant clinical professor of medicine at Vanderbilt University School of Medicine and an award-winning physician writer.Read more

Yasmine Ali, MD, is board-certified in cardiology. She is an assistant clinical professor of medicine at Vanderbilt University School of Medicine and an award-winning physician writer.

4 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Han JJ.Aeson—The Carmat total artificial heart is approved for enrollment in the United States.Artificial Organs. 2021;45(5):445-446. doi:10.1111/aor.13959Han JJ.Aeson—The Carmat total artificial heart is approved for enrollment in the United States.Artificial Organs. 2021;45(5):445-446. doi:10.1111/aor.13959US Food and Drug Administration.Early Feasibility Studies program.SynCardia.How does the SynCardia total artificial heart work?

4 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Han JJ.Aeson—The Carmat total artificial heart is approved for enrollment in the United States.Artificial Organs. 2021;45(5):445-446. doi:10.1111/aor.13959Han JJ.Aeson—The Carmat total artificial heart is approved for enrollment in the United States.Artificial Organs. 2021;45(5):445-446. doi:10.1111/aor.13959US Food and Drug Administration.Early Feasibility Studies program.SynCardia.How does the SynCardia total artificial heart work?

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Han JJ.Aeson—The Carmat total artificial heart is approved for enrollment in the United States.Artificial Organs. 2021;45(5):445-446. doi:10.1111/aor.13959Han JJ.Aeson—The Carmat total artificial heart is approved for enrollment in the United States.Artificial Organs. 2021;45(5):445-446. doi:10.1111/aor.13959US Food and Drug Administration.Early Feasibility Studies program.SynCardia.How does the SynCardia total artificial heart work?

Han JJ.Aeson—The Carmat total artificial heart is approved for enrollment in the United States.Artificial Organs. 2021;45(5):445-446. doi:10.1111/aor.13959

US Food and Drug Administration.Early Feasibility Studies program.

SynCardia.How does the SynCardia total artificial heart work?

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