Because the demand for donor hearts exceeds the supply, most people in need of a heart transplant will have to wait at least six months for one to become available.
Often those people can wait at home, but if both sides of a patient's heart are failing (a condition known as end-stage biventricular heart failure), they usually have to stay at the hospital until they receive a transplant.
Now, the European Commission has approved the sale of a new total artificial heart designed by French company Carmat to serve as a bridge to transplant — giving people with end-stage heart failure the ability to live outside a hospital until a donor organ is available.
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Designing an Artificial Heart
Carmat's artificial heart consists of three parts: an implantable prosthesis, an external hardware system, and a controller.
The prosthesis itself is an extremely complex device — a system of valves, pumps, sensors, cables, and other electronics, working in harmony to pump blood in and out of the implant.
The device needs to connect to an external hardware system, which weighs about 11 pounds and can be carried around in a pouch.
That system includes the batteries, which last about four hours — it's not much, but it gives users a lot more mobility than they'd have waiting for a transplant in a hospital.
The controller, meanwhile, is designed for use by the patient's medical team — it gives them the ability to track the artificial heart and make sure it's functioning properly.
On December 22, the European Commission (E.C.) approved Carmat's artificial heart for sale, making it just the second one on the market anywhere.
The other, made by Arizona-based company Syncardia, has been available in the E.U., U.S., and Canada for several years, but experts say that Carmat's heart has a few advantages.
The artificial heart has remained functional in at least one trial patient for more than two years.
For one thing, Syncardia's artificial heart is air powered with compressors a patient has to carry around in a backpack. Carmat's motors are powered by the less-obtrusive batteries — this makes it quieter than the air compressor device, too.
Carmat's heart also incorporates biological materials that may reduce a patient's need to take blood thinners, according to heart surgeon Vigneshwar Kasirajan, who is leading a clinical trial of Carmat's heart at Virginia Commonwealth University Medical Center.
"Overall, the design is a big step forward," he added.
Beating Back Heart Failure
Like Syncardia's artificial heart, Carmat's device is only approved for use as a temporary solution — it's specifically designed for patients who need a donor heart, but aren't likely to get one in the next 180 days.
However, the device has remained functional in at least one trial patient for more than two years, so the potential for it to give heart failure patients an extended lease on life outside the hospital is already there.
The company expects to begin selling its artificial heart under the brand name Aeson in Germany in the second quarter of 2021, with sales in France and potentially other E.U. nations to follow after.
The device will cost more than $180,000, and Carmat will need to work with insurers and governments to get the cost covered — otherwise, many of the people who need the artificial heart won't be able to afford it.
In the meantime, the company plans to launch a U.S. trial in the next couple of months, with the goal of securing FDA approval by 2024.
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