Take one hollowed-out tin of Kiwi shoe polish and stuff it with crude circuitry and gum it all together with some medical-grade epoxy. Place this "pacemaker" inside a desperately ill patient -- with the idea of using electricity to pace his foundering heart. Then, when the first pacemaker shorts out within three hours of the open-heart operation, repeat this procedure.
A recipe for disaster? On the contrary.
It's the story of Arne Larsson, a 43-year old Swedish man who was the recipient of the world's first (and second) implantable pacemaker at Sweden's Karolinska Hospital in October 1958.
Minnesota is well known as a medical-device haven after Medtronic co-founder Earl Bakken invented the first battery-powered pacemaker in 1957. But St. Jude Medical Inc. has a stake in the evolution of the device as well.
Through Oct. 26, Little Canada-based St. Jude will celebrate the 50th anniversary of the implantable pacemaker with a historical exhibit at the American Swedish Institute in Minneapolis.
Elema Schönander, the Swedish company that developed the implantable pacemaker, was ultimately absorbed by St. Jude, which maintains large manufacturing and development operations at its European base in Jarfalla, Sweden.
With $1 billion in annual pacemaker revenue, St. Jude is now the world's No. 2 maker of pacemakers behind market-leader Medtronic of Fridley.
As medical devices go, pacemakers seem to attract little notice from the investment community, even though the worldwide market for the device is more than $4 billion, and the device's growth in recent years has been steady, if unspectacular.
Most Wall Street analysts seem obsessed with the device's technologically sexier cousin, the implantable cardioverter defibrillator, which treats a different heart condition called tachycardia and sells for three times the price of a pacemaker.
These days, pacemakers are a far cry from that Kiwi shoe-polish tin. They're as small as a quarter and can last a decade inside a patient. They provide electrical stimulation only when needed, and send diagnostic information over the Internet to the patient's doctor. The original implantable pacemaker had just two transistors; today's models can have as many as 20 million in each device.
In the decades following the first procedure in 1958, no one would understand the technological continuum more intimately than Larsson, who was implanted with 22 pacemakers over his lifetime until his death in 2001. Remarkably, Larsson did not die of heart disease but of cancer -- and he outlived the inventor of the device and his implanting physician.
The Star Tribune recently spoke with Dr. Paul Levine, St. Jude's vice president of medical services, about the history -- and the future -- of the pacemaker. Here is a condensed version of the interview:
Q In the modern history of medical devices, how would you rank the invention of the pacemaker?
A It's major because it has increased the longevity and the quality of life in literally millions and millions of patients. It's interesting, when you go back over the medical literature from the early 1960s that talk about this new technology -- pacemakers -- it says there may be a role for it, but it would be very limited ... major centers would implant maybe a half-dozen a year. Now [pacemaker surgery is done] in virtually every hospital in this country and in most hospitals around the world.
Q Was the pacemaker controversial back in 1958?
A Oh, yes. Putting a metallic, foreign object into the body to artificially stimulate the heart went up against the will of God, according to some members of the clergy, who were preaching this from the pulpit. And there were newspaper columnists in Sweden at the time who said the procedure should not be done [for the same reason].
Q What's the real story behind the shoe polish tin story?
A Arne Larsson suffered from heart block, and was in the hospital for two months, fainting up to 30 times a day. His wife, Else-Marie, heard about a temporary pacemaker that was being developed and pleaded with Dr. [Åke] Senning, "Can't you do something to help my husband?" He and Dr. [Rune] Elmqvist said a temporary pacemaker wouldn't work: It's temporary, putting wires through the skin to the inside of the heart would lead to infection, and there would be all sorts of problems.
Q So that called for an implantable device?
A But they knew they couldn't put the whole device into the patient; with all the circuits exposed, it would short out. ... So they cleaned out a Kiwi shoe polish tin, put the various circuitry in it, backfilled it with a medical-grade epoxy and the wires were hard-wired into it. They opened the chest and sewed the wires onto the surface of the heart and they put the pulse generator in the upper area of the abdomen.
They put it in and everything was fine. Three hours later, when [Larsson] had a spell, guess what wasn't working? The pacemaker. Dr. Elmqvist had made two pacemakers. So in a single 24-hour period, Arnie Larsson not only got the world's first fully implanted pacemaker, he got the world's second fully implanted pacemaker.
Q Could the shoe polish tin story happen today? It seems so crude.
A The bottom line is, physicians are doing this kind of innovation all of the time, even if it's not FDA-approved. If you've done everything you know how to do, and the patient is still not responding, that's when individual physicians often try desperate maneuvers.
Like the use of pacemakers to treat heart failure. From a physiology standpoint, this makes absolutely no sense. Then a doctor in Austria published a paper back in 1990 reporting on 16 patients who had severe end-stage heart failure. Their option was to get a heart transplant or die. Not knowing what else to do, she put dual-chamber pacemakers in these 16 patients. Within three weeks, everyone was out of the hospital. There was still a high mortality rate over time, but four of them were still alive five years later.
Q What sort of future advances can we expect from the pacemaker?
A The same technology can be applicable to any tissue in the body that is capable of being electrically stimulated. That includes the brain, using neurostimulation to treat pain, tremor, spasticity, paraplegia to restore action to the muscles so people can walk again. We could stimulate the stomach when someone starts to eat so they may feel like they're full, so they stop eating, treating obesity. It's almost unlimited.
Q With stem cell and gene therapies being developed to treat heart disease, do you see the pacemaker fading away ultimately?
A It won't go away entirely. But yes, a lot of the conditions we treat with a pacemaker today ... we may treat with stem cells, with genetic engineering. We may be able to regrow specific parts of the heart so that in the future we may not have to implant a device.
Janet Moore • 612-673-7752