This brand-new 1500 m2 factory located in Bois-D'arcy, near Paris, does not manufacture car parts or aircraft engines. No, it makes hearts. The first Carmat artificial heart manufacturing plant has just obtained its certification and is moving to the industrial stage. 800 hearts will be produced here every year.
Phe new site is currently dedicated to the assembly of bovine pericardial membranes (the envelope surrounding the heart) on a part of the implant that will be in contact with blood flows, a fundamental step for better biocompatibility. The operation is now performed by a robotic arm to avoid the slightest tear, air bubble or fold on this fragile and ultra-thin biomaterial - between 0.3 and 0.5 millimetres. Microscopic defects but potentially very detrimental to the proper functioning of the prosthesis.
Previously, this stage was done by hand, which "required incredible dexterity" and a week's work, but with "90% of scrap" despite everything, Carmat's general manager, Stéphane Piat, told AFP after meeting him on site. Today with robotisation, "we need 10 minutes and we're close to 0% of scrap" on this particular step," he says.
Up to 800 prostheses per year
However, it will take several days for the complete assembly of the Carmat core, which comprises some 400 parts: biomaterials and plastics, but also silicone, titanium and electronic components.
The other phases of production are for the moment still being carried out on the historic Carmat site in Vélizy-Villacoublay, also in the Paris suburbs. But they are in the process of being transferred in turn to Bois-d'Arcy, which will have a total of around fifty employees.
"Within a few weeks, we'll be able to produce the Carmat prosthesis from A to Z here for a potential maximum capacity of "700 to 800″ units per year." "predicted Mr. Piat.
The company has produced a total of about 50 prostheses to date, which are being used for in-house testing as well as for clinical trials.
Carmat's pivotal clinical trial, currently underway in Europe, involves approximately 20 patients with end-stage heart failure, at least 10 of whom have been implanted to date.
This study should make it possible to obtain a CE marking next year, the regulatory key to starting marketing in Europe, according to the company's schedule.
Tests inspired by aeronautics
The primary endpoint of this study is survival of more than half of the patients at six months post-implantation. One of them also successfully underwent a heart transplant this summer, after living with an artificial heart for eight months.
A very encouraging first for Carmat. However, his prosthesis is still intended to become a "definitive therapy" for end-stage heart failure, rather than just a "bridge" to a human transplant, says Carmat. Piat.
"There are more than 100,000 patients in Europe and the United States waiting for heart transplants from just 5,000 donors per year worldwide."he points out.
"Only experience with patients will tell us how long the device can really last.... All parts have been tested separately for years, up to 10 years, using aerospace-inspired strength tests, he adds.
In Vélizy-Villacoublay, several complete artificial hearts are also running permanently in liquid baths. The oldest of them has been beating for more than four years, at 145 beats per minute. This is about twice the average human heart rate.
But while Carmat says his system is becoming more robust and reliable, the company has also experienced a number of setbacks and unforeseen events in the past, which prompts him to be cautious. "We have to be careful."Mr. Piat repeats, while refraining from mentioning the future price of the prosthesis.
A luxury technique
This technique, regardless of the company's recent news, embodies a true technological feat and the culmination of twenty years of research. However, it probably comes a little late in terms of the promises of so-called "regenerative" medicine.
Cellular therapies under development are indeed demonstrating their potential and progress every day. In cardiology, if they keep their promises, they will seriously deplete the "reservoir" of patients with terminal heart failure in the medium term. But for the time being, this is not yet a problem for Carmat, whose revolutionary device has the major advantage of being able to make up for the crying lack of donors for heart transplants in all countries, perhaps while waiting for new treatments.
Every year, thousands of patients die for lack of organ donors. Currently, only 350 to 400 patients with end-stage heart failure can be transplanted in France, while the need is three times greater. The level set by Carmat to implant nearly 1,000 to 2,000 patients each year remains an ambitious goal, if the company succeeds in reaching it.
For, although the treatment of Carmat does not require the lifetime administration of immunosuppressive drugs, the device maintains a high level of care, the estimated cost of the entire device to date being in the order of 200 to 250,000 euros, to which must be added the cost of the implantation surgery. This cost makes the widespread distribution of this artificial heart reprehensible for health organizations, all the more so if it only slightly reduces the risk of short-term multiorgan failure in the patient.
Source: AFP
Header image: An employee of the Carmat company shows an artificial heart prosthesis, August 29, 2018, in Bois-d'Arcy (AFP-BERTRAND GUAY)
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