Carmat SA (Villacoublay FRA) announced that its artificial heart has been implanted for the first time in an important clinical study that may lead to European regulatory approval.Carmat announces that its artificial heart has been implanted for the first time Click To Tweet
It is similarly sized to a real heart and designed to closely mimic the natural biomechanics of a human heart. Powered by an external power source, the device may have the ability to sustain patients continuously for years if the trial and subsequent observations prove successful.
Carmat said the implantation of its bioprosthetic heart was carried out with the approval of the French national agency for safety of medicines and health products and the country’s patient protection committee. It added that it would not publish “specific information concerning the implantations of each patient involved in the study or their condition.”
According to one report, the bioprosthetic heart was created by bringing together an unusual team consisting of Dr. Alain Carpentier, the developer of mitral valve repair, and personnel from jet airplane maker Airbus SAS (Blagnac FRA).
This was necessary because while the heart may be fairly well understood, moving fluids around inside and outside it without creating stress and turbulence, and doing so consistently for years without a break, is a major engineering challenge.
Some observers say there is a lot of hope in the medical community that artificial hearts will not only serve as bridges to transplants, but may become a regular therapeutic long-term option for those with failing hearts. Carmat is as well poised as anyone to achieve that, according to some analysts.
Carmat’s shares jumped after the announcement and closed the week up 15% at 40.50 euros in Paris. The company’s shares have lost 1% so far this year, valuing it at about 207 million euros ($230 million). It reported a net loss of 17.5 million euros in 2015.
Steve’s Take: After reading the accounts of this gritty, eight-year-old French company’s efforts to nudge its particular artificial heart one step closer to the market, I was struck by my sudden awareness that today, the devices in this rarified space aren’t just meant to bridge people with failing hearts to an eventual heart transplant. They also are meant to serve as what’s termed “permanent use,” or “destination therapy.”
With advances in not just the medical device technology but also in the field of battery technology, such destination hearts could easily last up to 30 years. As my friends at Germany-based and Europe’s best biotech newspaper Labiotech elegantly put it, this new Carmat device would:
“solve one of the life-long problems for humans—-how to replace a broken heart. Though it is battery-dependent, this artificial heart would wholly replace the one beating in your chest.”
Carmat’s goal for an upcoming, larger study is to have its artificial heart stamped by CE (Conformité Européenne) so it can be sold into the European Economic Area (EEA). Its artificial heart is cheaper than a heart transplant but still costs well over €100,000. And because of its larger size, the heart is reserved for a very limited patient set composed of obese men whose transplants failed.
So why invest in this space?
The need for donor hearts is constantly growing as heart disease continues to claim an increasing portion of the world’s population. However, the number of donor hearts available for transplant has been flat in some countries and is declining in others, according to 2013 figures from the Registry of the International Society for Heart and Lung Transplantation.
To save adults and adolescents from dying of end-stage biventricular (both sides) heart failure, medical teams from around the world have developed 13 different types of artificial hearts that have been implanted into patients since 1969.
More fun facts: According to the U.S. Department of Health and Human Services, over 4,000 people wait for a donor heart transplant on any given day, while the supply of approximately 2,300 donor hearts annually has been flat in the U.S. for over 20 years. There have been 1,413 implants of all artificial heart designs from 1969 to September 5, 2014. The SynCardia temporary Total Artificial Heart and its direct predecessors account for 1,352, or 96%, of all implants.
Obviously, an artificial heart must fit into the patient’s chest without causing complications. In its well-documented PR release, SynCardia notes that its rival Abiomed’s replacement heart, developed in Massachusetts, weighs 1,090g and costs $250,000, while the Carmat heart, weighing 900g, carries a price tag of $181,000 to $223,000.
The SynCardia heart ($124,800 plus Freedom driver service charges) weighs just 160g–less than half the weight of a human heart–and is similar in size to an average human heart, which makes more patients eligible for implantation, according to their PR material.
And get this. RT.com reports that Siberian scientists have created an artificial heart they claim will be up to five times cheaper than its Western alternatives. Doctors hope to test the first implants on animals this autumn. According to their scientists, their artificial heart will have:
“a unique design that will be different from other hearts available or currently being developed in Russia and abroad.”
The new Siberian artificial heart will also be cheaper–approximately $31,000-$47,000. While the new heart is designed to last up to 30 years, the cardio device can also be implanted in patients waiting for a heart transplant, according to Dr. Aleksey Fomichev from the Novosibirsk State Research Institute of Circulation Pathology.
But why am I thrown by this revelation that a permanent artificial heart—-perhaps good for 30 years or more–is literally just around the corner? It’ll be here a lot sooner than DNA-optimized versions using stem cells (precursors to other sorts of cell) to grow organs such as hearts from scratch.
The advent of permanent artificial hearts brings the likely challenge of access to them. If longer life is expensive, who gets it first? As The Economist points out, income already is one of the best predictors of lifespan.
“Widening the gap with treatments inaccessible to the poor might deepen divisions that are already straining democracies,” the authors suggest.
Yeah, I guess.
This vision of the future with artificial organs is actually NOW, what with, among others, artificial bladders, ears, eyes, livers, lungs, ovaries, the pancreas, the thymus, the trachea, and even the placenta. Not to mention all the hips, knees…but those technically aren’t “organs.”
Still, this vision of the future depends on one central hypothesis, namely, that a longer existence is also a healthy one. Again drawing from the Economist,
“Bodies have evolved to be throwaway vessels for the carriage of genes from one generation to the next. Biologists have a phrase for it: the disposable soma.”
So this throwaway carcass of mine explains not only the “dwindling of prowess experienced by all as time takes its toll, but also why dementia, cancer, cardiovascular problems, arthritis and many other maladies are guarded against in youth,” but then stuffed into old age once reproduction has concluded. These maladies must still be treated if a long and healthy life is to become customary. And even a healthy brain may age badly.
Others may fancy the promise of a longer life, well lived. But do I want to live to age 120 years with my artificial ticker, pancreas, lungs and liver, yet be unable to identify my great-great grandchildren, let alone my surviving firstborn? Yes, I am “alive,” but with a brain evolved to contain just 70 to 80 years’ worth of memories, at age 120 I have few recollections dating back much more than five minutes.Steve's Take: Living longer may not be a panacea if the brain can't keep up Click To Tweet
Is this what I fancy? Not yet.
Of note: The NCD (National Coverage Determination) for Artificial Hearts, released by the Centers for Medicare and Medicaid Services (CMS) in May 2008, concluded that additional clinical research would be appropriate under the Coverage with Evidence Development aspect of CMS’s coverage authority. The NCD specifies that artificial heart devices are covered only when provided to Medicare beneficiaries when the device is implanted as part of a CMS approved study.
If you aren’t in an approved study, bring your checkbook for your Carmat, or other artificial heart. It’s the one tied to your Fidelity retirement account.