French prosthetics firm Carmat on Monday sold its artificial heart for the first time since its founding in 2008. The heart was implanted into an Italian patient.
The first artificial heart sold
The firm secured a European CE marking in 2020 for the sale of the prosthetic heart making it a bridge to transplant. The certification was based on results from a study called PIVOTAL, running since 2016. The results of 11 patients received in November 2019 showed that 73 percent of patients survived for six months after the transplant and lived successfully. Additionally, the company stated that the first commercial sale of the artificial heart is a milestone. After all, it opens up a new chapter for the development of both the company and human lives.
“The operation, performed by the team headed by heart surgeon Dr. Ciro Maiello at the Azienda Ospedaliera dei Colli hospital in Naples, one of the centers with the greatest experience in the field of artificial hearts in Italy,” stated Carmat. “This was the first time that one of our artificial hearts was used outside clinical trials,” stated a spokesperson. However, the national healthcare system in Italy does not cover the surgery charges. This is because it does not cover treatment that has not been in use for a long time. The procedure costs over $177,000 and, covered by a regional healthcare system.
Gateways to new research
Additionally, Carmat announced that the first implantation of an Aeson heart into a patient in the US took place on July 15. However, it is a part of a clinical study at the Duke University Hospital in North Carolina. The study is on the watch for them more patients who can take part. It is approved by the US Food and Drug Administration (FDA). Results from this study will open up avenues for people needing a heart transplant in the US.
