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

Medical staff prepares Carmat's Aeson total artificial heart

Courtesy Stephanie Lopez / Duke Health

Key Takeaways

  • For the first time, a U.S. patient received an Aeson total artificial heart device implant.
  • The device, made by French medical technology company Carmat, was approved by the FDA in February 2021 for a small-scale clinical trial. 
  • Total artificial heart devices like Aeson help patients manage late-stage heart failure as they wait for heart transplants. 

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.

The 8-hour surgery took place as part of a clinical trial at Duke University Hospital. The trial is investigating the use of the Aeson device, created by a French medical technology company called Carmat.

"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 with biventricular 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.

The Food and Drug Administration (FDA) approved Carmat to begin testing its newest version of Aeson in U.S. patients back in February as 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 funding to 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

Currently, the only FDA-approved total artificial heart device is the TAH-t system by SynCardia. The larger 70cc and smaller 50cc devices are made of bio-friendly plastic and pump blood through the body at a fixed rate.

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. 

The device is powered by an external battery pack that patients can carry with them, and it's connected through a tube in the skin. And, on an external monitor, it shows the user’s blood pressure.

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. 

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, MSCI
Yasmine Ali
Personal Detail

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.

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4 Sources
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  1. 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

  2. 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 

  3. US Food and Drug Administration. Early Feasibility Studies program.

  4. SynCardia. How does the SynCardia total artificial heart work?