Carmat, a French startup that claims it’s making the “world’s most advanced artificial heart”, recently announced it plans to start selling its device in Europe in the second quarter of this year. That’s major, as currently there’s only one other company, SynCardia, which has received regulatory approval for a total artificial heart device.
Artificial hearts have been around for more than 80 years, with Dr. Vladimir P. Demikhov implanting the very first total artificial heart (TAH) device into a dog in 1937. But given the heart’s central role in how a body functions, and the sheer complexity of developing one that would work in humans long-term, it wasn’t until the 1980s that TAH devices were implanted in people with the aim of becoming a permanent solution. Even now, they’re devices that are mostly meant to serve as a temporary “bridge” for those on the waiting list for a heart transplant.
Carmat’s TAH is interesting because it’s meant to be fully implantable and used in cases of terminal heart failure. It features embedded sensors and hydraulics to mimic human bloodflow, as well as chemically treated animal tissues to reduce the likelihood of clots. Unlike other TAHs, it can also adjust the flow rate of blood in real time depending on demand (i.e., exercise would require higher flow, etc.). It weighs 900 grams — about three times heavier than the human heart — and is powered by lithium ion batteries to provide four hours of mobility. According to Smithsonian Magazine, the idea is Carmat’s TAH should be able to operate continuously for up to five years while also letting the person with the device potentially live a “normal” life.
But why now? Carmat didn’t pop up overnight; the device has been in development for 27 years. The big thing is that at the end of 2020, Carmat got European regulatory approval in the form of the CE Mark. Getting the CE Mark is Europe’s equivalent of U.S. Food and Drug Administration approval — and a necessary requirement before experimental medical (or medical-adjacent) technology can be more widely used or sold to consumers. As you might expect, Carmat’s stock jumped 34% and the company’s valuation jumped to $US496 ($646) million once news broke that Carmat had obtained the CE Mark, a process which took 10 years.
Health tech development is notoriously slow, which compared to other types of technology is a good thing. because implantable heart devices have the potential to go seriously wrong in ways that gadgets like smartphones or tablets can’t. Stories about emerging or “proof of concept” devices like these often nab headlines but then run out of funding before they ever get the chance to hit the market. So in that sense, the fact that Carmat has reached this stage is pretty exciting.
That said, there’s a caveat: Even though Carmat is expected to start selling its device in Europe, targeting those with terminal heart failure, it still needs to undergo the approvals process with the FDA before it can be available in the U.S. On that front, Carmat is planning an FDA feasibility study, with the plan to enroll 10 patients. Last year, the company also announced that it had achieved a major milestone in that a patient had passed the two-year mark of living with its bioprosthesis.
So no, Carmat’s TAH isn’t likely to magically replace SynCardia overnight. (SynCardia is the only TAH maker with regulatory approval from the U.S., Europe, and Canada.) However, more options are always good when it comes to technological advancement. This is especially true when you consider that heart disease rates are climbing, patients often have to wait more than six months on the heart transplant list, and that across Western Europe, there are roughly 2,000 patients suffering from biventricular heart failure on transplant waiting lists.