Heart failure is a condition where the heart’s muscles fail to contract enough to pump blood around the body. Although lifestyle changes may help improve a heart failure patient’s outcome, the only permanent treatments currently available are a valve replacement, ventricular assistance device – used for single ventricular failure – or heart transplant, for end-stage heart failure.
The latter treatment poses a difficulty: the number of patients waiting for a transplant far outweighs the number of donors available. Unfortunately, this means that many patients will pass away while waiting for a donated heart.
A French MedTech company named CARMAT has developed an artificial heart that could potentially replace the need for donor hearts. The device, called Aeson, consists of biocompatible bovine-origin valves that can pump blood in one direction through pulsatile beats. It even contains sensors so that it can alter the blood flow according to the patient’s physiological needs. All this is powered using an external battery-powered controller that the patient has to carry around. This gives them approximately 4 hours of independent mobility.
In 2016, the company began its clinical studies in Europe (called PIVOTAL). In 2019, results for the first 11 patients were evaluated: 73% of the participants lived for 6 months or until they received a donor heart transplant during this time. Following this, the company received a CE in December 2020 which approved commercial sales in the continent. However, the device is only to be used as a “bridge to transplant” i.e. a way for the patient to continue living while they wait for their donor heart.
In July 2021, the Aeson was sold for use by an Italian patient in Naples. The surgery was done by Dr. Ciro Maiello, a cardiac surgeon at the Azienda Ospedaliera dei Colli hospital in Naples. This hospital is one of the only centers in the country whose doctors have experience with artificial hearts. The surgery cost about 150,000 euros ($177,000) and was covered by the regional healthcare system.
In the same week, Duke University School of Medicine commenced CARMAT’s US clinical trials by implanting their first volunteer with the Aeson device, which has received FDA approval for a clinical study. The volunteer, Mathew Moore (39) was previously expecting to undergo bypass surgery. However, his condition worsened, leaving doctors with no other choice but a transplant surgery. Instead of waiting for a donor, however, the doctors decided to enroll him as a study participant, the first of the 10 planned.
– Rachel Moore, Matthew’s wife, a practicing nurse
“Both Matthew and I are so grateful that we’ve been provided an opportunity to participate in something that has the potential to have an impact on so many lives . We are just taking it day-by-day and hope everything continues to progress well.”
According to the company, the device will be available commercially in Germany and France by the end of this year.
Source: Duke University School of Medicine