Halloween, 1957: And the lights are out across Minnesota.
For Walton Lillehei, this is a crisis.
A storm has knocked the power out in his Minneapolis hospital leaving his cardiac patients in the dark — and in jeopardy.
Lillehei, who would become known as “the father of open-heart surgery,” is concerned about his recovering patients whose survival depends upon their pacemakers.
Bulky as car batteries, these pacemakers rely on AC power, which means blackouts can be fatal.
And this one is.
A pediatric patient hooked up to one of the crude devices dies.
Determined to find a solution to this problem, Lillehei looks to an electrical engineer who had co-founded a medical equipment repair shop in his Minneapolis garage in 1949 with his brother-in-law Palmer Hermundslie.
The engineer is Earl Bakken. The name of his shop, Medtronic.
Electricity is Life
Throughout his life, Bakken was fascinated by Frankenstein, Mary Shelley’s classic tale of a mad scientist who harnesses the power of the heavens to bring his creature to life.
As a boy, Bakken saw the 1931 film adaptation of the novel at The Heights Theater in his hometown of Columbia Heights, Minn.
At a workbench in his childhood home, the young Bakken experimented with gadgets of all kinds, taking apart clocks and building small-scale devices, all of which would influence and inform his later work.
As Adrian Fischer, the curator at the Bakken Museum in Minneapolis, explained during a guided tour of the museum, Bakken, too, believed in the power of electricity; not to create life but to restore it.
“When Earl started Medtronic, it was the starting point of using electricity to heal and cure.”
Adrian Fischer
Today, the Bakken Museum resides in the West Winds mansion, which Bakken purchased in 1976 to hold an extensive collection of books and devices from his Medtronic offices. Fischer said Bakken was attracted to the gothic mansion because it reminded him of the home from Frankenstein.
But it was his belief that “electricity is life,” Fischer emphasized, that provided Bakken with the spark to solve Lillehei’s dilemma.
Within weeks, Bakken had developed the first battery-operated pacemaker based on a transistor circuit he read about in Popular Electronics magazine.
Bakken, Fischer said, was as much as pragmatist as he was a visionary. He modified the transistor circuitry to fit within a four-inch-square metal box with outside terminals and switches.
Bakken’s original sketch of this circuitry is among the museum’s collection.
Though large compared to today’s pacemakers, Bakken’s battery-operated device was small and light enough to wear and marked a turning point in patient care that would revolutionize the medtech industry.
“When Earl started Medtronic, it was the starting point of using electricity in modern devices to heal and cure,” Fischer said.
Though the idea of using electricity to animate life was made famous by Shelley, then adapted by Bakken, the concept of using electricity to heal dates back centuries.
Along with its assortment of vintage devices, the Bakken boasts an impressive collection of rare books on science and medicine, including Speculum naturale (Mirror of Nature) by Vincent de Beauvais, published in 1280.
The massive tome, one of several volumes on the natural world, mentions the use of electric eels to soothe pain.
“Very early on, many centuries ago, people used electric fish to heal the body,” Fischer said, noting that today electrical stimulation is common therapy for treating a range of ailments.
Bakken’s understanding of the fundamental role electricity played in the human body and his ability to apply that in his first device, is one of the attributes that underscores his genius, in Fischer’s view.
“What I think set Bakken apart, and what sets Medtronic apart, was his emphasis on the patient,” Fischer said. “He knew that in the end these devices would decide life and death. That people would depend on them.”
Rob Kowal, a former electrophysiologist at Baylor Heart and Vascular Hospital and current vice president and general manager of Medtronic’s cardiac pacing therapies (CPT) division, agreed that Bakken’s knowledge of electricity — especially its role in the heart — has proved prescient.
Today, the American Heart Association estimates three million people across the world have a pacemaker, with approximately 600,000 implanted each year.
Keeping Pace
Cardiac pacing has come a long way since Bakken transformed the industry from his Minneapolis garage in 1957.
But it’s still unfolding, which is why Kowal finds the field so exciting.
“You think the technology would plateau,” he said. “But just when you think it has, something new comes along.”
As is often the case, Medtronic is ahead of that curve.
“First there was the external pacemaker, then the implantable device,” Kowal said. “And when you look at the traditional pacemaker that sits under the skin and the chest with wires in the heart, which we call transvenous pacing, the original ones lasted two to three years and were the size of a hockey puck. Now, the current ones are the size of an Oreo cookie, can last up to 17 years and have a whole array of features. They can communicate remotely. They can withstand MRIs. They can do a variety of different things earlier versions could not.”
But though these advancements were great, Kowal added, they just weren’t good enough. The focus became on how to make them even better.
And Medtronic did. In 2015, the company invented Micra, the first leadless pacemaker, which the US Food and Drug Administration approved in 2016.
Micra, Kowal explained, is a minimally invasive device — about the size of a vitamin capsule — implanted directly into the heart. This eliminates the necessity of leads as well as a surgical incision — or pocket — under the skin. The device is intended to treat patients who experience symptoms related to bradycardia, a condition in which the heart beats too slowly.
“So now we have a device that’s 50 to a hundred-fold smaller than the original, with no leads and no need for a surgical pocket,” Kowal said. “It’s the ultimate patient experience because they feel better. They don’t even know they have it.”
Medtronic has further improved upon Micra with the AV2 and VR2 models, both of which are FDA-approved and stamped with the CE Mark, the European Union’s regulatory equivalent.
The battery life of the Micra AV2 is 16 years, while the VR2 can last as long as 17 years. These durations are approximately 40% longer than prior iterations, meaning more than 80% of the patients who have them will only need one.
“What’s exciting and fun about working at Medtronic is we just don’t think about how we can make incremental changes to improve on our technology, but about how can we disrupt the whole area.”
Rob Kowal
Medtronic has since improved on the transvenous pacemaker as well, which, Kowal noted, is more suitable for certain patients.
By changing the positioning of the lead to target a specific area of the heart, the transvenous device initiates “conduction system pacing” — an emerging technique that stimulates the heart’s natural electrical activity rather than the heart muscle directly.
Medtronic received regulatory approval for this system to treat two crucial areas of the heart’s conduction system: His-bundle in 2018 and left bundle branch in 2022.
“This has changed the whole spectrum of pacing,” Kowal said, adding every change Medtronic has made to these systems has attacked a limitation of a prior version. “What’s exciting and fun about working at Medtronic is we just don’t think about how we can make incremental changes to improve on our technology, but about how we can disrupt the whole area.”
But even with the innovation represented by Micra, which Kowal believes is still the most advanced pacemaker on the market, he’s not satisfied and sees even further progress ahead in pacing technology — in both the transvenous and leadless platforms — and for patients with rhythm disorders.
For transvenous pacemakers, Kowal said the focus remains on making improvements through the heart’s conduction system, while innovation on leadless technologies seeks to cover a broader range of disorders.
“Right now, our leadless portfolio covers about half of the pacing needs a patient may have. So, our future devices will be designed to cover any pacing need,” he said. “We want to expand to the entire pacing market with the same approach of a single device. Ultimately, the goal is to merge the two platforms so that all patients can benefit from a single leadless device to meet any need they may have.”
“This is what’s exciting, to be able to share this patient information with providers and bring peace of mind to family members and caregivers.”
Paul Iaizzo
Eliminating leads and the requirement of a surgical pocket, Kowal said, reduces the potential of complications that can come with pacemaker implantation. Procedures with Micra devices, according to Medtronic data, have more than a 99% implant success rate, with low incidents of dislodgment and infection.
Medtronic also broke new ground in 2002 with the introduction of CareLink, the industry’s first remote monitoring system that securely sends pacemaker data to the user’s physician over the internet.
Research has shown that remote monitoring not only reduces hospitalizations but also provides patients with a sense of freedom and security.
Remote Monitoring Takes Patients Everywhere
Remote monitoring allows doctors to keep tabs on their patients wherever they are; even if, like Elliot Awin, they are rowing across the Atlantic Ocean.
In 2014, the then-27-year-old Awin was diagnosed with both Wolff-Parkinson-White syndrome and atrial fibrillation, arrhythmias that, if they occur together, can be life-threatening.
In 2020, Awin, who became a fitness advocate after his doctors advised him to stop playing rugby, received a Medtronic transvenous pacemaker.
Then, in 2023, Awin became the first person with a pacemaker to row solo across the Atlantic. And, Kowal said, they were able to track him the entire way.
“The key message is that the goal of these devices, whatever your age, is to get you back to a situation where your limitations are reduced or eliminated,” Kowal said.
While Kowal added he sometimes misses the personal connections he made with patients in private practice, the trade-off is that at Medtronic he can engage with them on a much wider scale.
“Whether it’s as a physician or in my role now at Medtronic, it all comes back to our slogan of ‘alleviate pain, restore health, extend life,’” Kowal said. “That’s the guidance every day.”
The Visible Heart
Whatever innovation in cardiac care Medtronic develops in the future, it’s a safe bet it will go through the University of Minnesota’s Visible Heart Lab (VHL).
Co-founded in 1996 by Paul Iaizzo, a professor at the University of Minnesota Medical School and director of Visible Heart Laboratories; Tim Laske, vice president of research in the Medtronic cardiac ablation solutions operating unit; and Mark Hjelle, an engineer at Medtronic, the groundbreaking lab allows researchers, scientists, doctors and students to see how medical devices perform inside a beating heart.
In 1997, the lab signed a contract with Medtronic. Iaizzo told Medtech Insight that the contract has been extended to 2030.
“It’s a collaboration in the truest sense,” Iaizzo said, adding that the lab tests Medtronic equipment in its early development stages, while also training graduate students at the university and physicians from around the world either at the lab or through virtual seminars.
The lab, Iaizzo explained, uses state-of-the-art equipment and techniques to reanimate hearts, providing opportunities for learning and technological advancements simply not possible otherwise.
The other benefit the lab provides, Iaizzo noted, is to prepare physicians for emergencies, the way airline pilots train for worst-case scenarios in a flight simulator.
“Because it’s a reanimated heart, you can purposefully create problems that require a bail-out technique,” he explained. “So, you have the opportunity to work on things when they are going well but then also when they are going wrong, and you have to figure out corrective measures.”
Work done in the lab, Iaizzo said, was instrumental in developing the transformative Micra and transvenous pacemakers.
While most of the reanimated hearts the lab receives are swine, some are donated human hearts that are not viable for transplant.
Since the lab’s inception, Iaizzo said they have reanimated 98 human hearts. When this happens, the process of reanimation is the same as receiving a heart for transplant, with a narrow window to get the organ to the lab and prepped.
“We have a whole team ready. The heart can’t be damaged, and it needs to have had reasonable function in the donor,” he said. “So, all the stars have to lock on, and that’s rare.”
Still, the reanimated pig hearts provide enormous insight into research and technological progress. As Iaizzo pointed out, pig hearts share significant structural and functional parallels to human hearts with both having four chambers, four valves, and a comparable blood flow mechanism.
The lab commonly tests devices such as pacemakers and stents and practices procedures like ablations and valve replacements, all of which exponentially increase the likelihood of success in patients in the real world.
“Imagine, Earl walks into the hospital and sees his prototype device keeping a child alive. He actually got to see that.”
Paul Iaizzo
Like Kowal, Iaizzo sees even greater innovation down the road and believes implantable sensors allowing for remote monitoring and telemedicine will pave the way.
Iaizzo told the story of his mother, who lived to the age of 90 after receiving a valve replacement and a Micra pacemaker. One day, she received a call from her cardiologist who was concerned because he had detected that she was in a-fib. He instructed her to immediately take an aspirin to reduce her stroke risk, then put her on an anticoagulant the following day. Iaizzo said his mother, who lived alone, was then monitored remotely for any further symptoms.
“Now that was peace of mind for her, some peace of mind for her cardiologist, and was peace of mind for me,” Iaizzo said. “This is what’s exciting, to be able to share this patient information with providers and bring peace of mind to family members and caregivers.”
Not Just a Matter of the Heart
In the early 1960s, Bakken drafted a “100-year plan for Medtronic” outlining parts of the human body that could benefit from electrical implantable devices. And he lived to see much of that plan come to fruition.
Though the company’s roots are in the heart, Medtronic’s reach today extends to 150 countries and every part of the human body with solutions for treating more than 70 health conditions.
In 2023, Medtronic says its therapies improved the lives of 78 million people — or two “every second of every hour of every day.”
This is illustrated in the work of the Medtronic’s pelvic health business, whose president Emily Elswick discussed her team’s efforts to help those with overactive bladder and fecal incontinence: Conditions, she said, that often go untreated due to the stigma that comes with them.
And these issues, as Elswick told Medtech Insight, are pervasive, with overactive bladder affecting one in six adults and fecal incontinence one in 12.
Making matters worse, these conditions — especially fecal incontinence — have a negative impact on every facet of life for those suffering with them.
They prevent patients from going out to dinner, the movies, family events or traveling, and get in the way of personal relationships because of the embarrassment they cause.
“I’ve had three kids myself. I know many women who could benefit from these treatments. I’m personally driven to raise awareness about these issues.”
Emily Elswick
Incontinence can also lead to other health problems, especially among older patients who are prone to injuries from falling after getting up during the night to use the bathroom.
But it does not have to be this way, Elswick said, as there are solutions. And as in the cardiac space, Medtronic has been out front.
In 1997, the FDA granted Medtronic premarket approval for its sacral neuromodulation (SNM) system to treat the symptoms of incontinence two decades before anything similar came to market.
Proving Bakken’s theory of electrical implantable devices to heal the body true, Medtronic’s system features a device that the untrained eye could mistake for a transvenous cardiac pacemaker.
Embedded into the sacral nerve, or the fat of the buttocks, the “pacemaker for the bladder” sends messages from the bladder telling the brain when to void and when to not.
“It’s really amazing that this technology all started with Earl Bakken back in his garage,” Elswick said.
Since it developed the SNM system, Medtronic has improved upon the technology, particularly battery life, which now lasts around 15 years, meaning that a single battery will last many patients a lifetime. And for those who need a replacement, the procedure, Elswick said, is simple.
But like Kowal, Elswick is not satisfied with the technology despite the advancements in SNM therapy.
“What’s more exciting is what’s coming next,” she said, alluding to Medtronic’s implantable tibial stimulation device, which is currently under FDA review.
The leadless device — “about the size of a stick of chewing gum” — fits under the ankle and controls the bladder by stimulating the tibial nerve.
Established research, according to Medtronic, has shown that tibial neuromodulation is a proven therapy to help restore bladder control and improve the quality of life for those struggling with incontinence.
Elswick noted that women, because of childbirth, menopause, and other anatomical difference, are more likely to have incontinence than men.
“I’ve had three kids myself. I know many women who could benefit from these treatments,” she said. “I’m personally driven to raise awareness about these issues.”
Medical Alley
While Earl Bakken was the driving force behind Medtronic’s rise from a humble repair shop in an unheated garage to the world’s largest medtech company, he is also credited with the growth of what’s called “medical alley,” a region that today spreads across the entire state.
But it’s not just a region.
The Medical Alley Association comprises more than 800 partner healthcare organizations across the world, including Medtronic as well as Boston Scientific and the Mayo Clinic.
In Minnesota alone, the organizations in the association’s network employ more than 500,000.
And according to Roberta “Bobbie” Dressen, president and CEO of the Medical Alley Association, headquartered in Golden Valley, Minn., the group as well as the region exist because of Bakken.
“We want that kindergartner living in a rural part of the state to have the confidence that she can pursue a career in science or engineering or math, and that she might be the next Earl Bakken and invent a medical device we haven’t heard of yet.”
Stu Silberman
As Dressen explained to Medtech Insight, Bakken was compelled to address the brain drain from Minnesota that was occurring 40 years ago. There was an exodus, according to Dressen, of scientists and engineers from major companies that today many would not associate with Minnesota, such as Honeywell, Control Data, and Hewlett-Packard.
Bakken also realized that the top minds leaving the state were needed at Medtronic. So, he teamed up with representatives across healthcare, including the pharmaceutical industry, and reached out to the state’s governor at the time, Rudy Perpich.
With Bakken leading the effort, these stakeholders created Medical Alley to focus on economic and trade development and create the workforce needed to sustain these corporations.
“But more than that, Earl Bakken helped to create an enriched community where people wanted to live and raise families,” Dressen said. Today, many Fortune 500 companies, such as General Mills, Pillsbury, and Cargill are based in Minnesota, and the medtech industry is now on par with agriculture as the top driver of the state’s economy.
“And Medtronic was at the foundation of that. Medtronic excels as an organization,” added Dressen. “It has evolved over time and remains a leader to this day.”
What’s Possible?
If you ask anyone at Medtronic what’s possible for the future of medtech technology and the patients its designed to treat, you will get the same answer: “Anything.”
And there are reasons for that.
In 1977, Medtronic introduced the Medtronic-Hall mechanical heart valve, an implantable titanium device that became widely used in aortic and mitral valve replacement technology.
Turning once again to electrostimulation technology for pacing the heart, Medtronic, working with French doctors, pioneered the first deep brain stimulation system to treat movement disorders in 1987.
Then, in 1993, the company introduced its first implantable cardioverter defibrillators, which, unlike prior pacemakers that treat bradycardia, an abnormally slow heart rate, treat tachycardia, a condition when the heart beats too fast.
And in 2015, Medtronic acquired Dublin-based healthcare products firm Covidien, further solidifying its place as a global medtech leader.
The North Star
Tracing the company’s history back to the garage where Bakken first opened his repair shop in 1949, the future that Kowal, Elswick, and Iaizzo envision for Medtronic and patients comes into view.
It’s represented, Dressen noted, on the new Minnesota state flag that was unveiled in May of last year, which features an eight-pointed star symbolizing “the North Star State.”
There’s tangible evidence for this link as well.
Today, for instance, the Visible Heart Lab is housed in a basement on the University of Minnesota campus, which is the same room where Bakken developed his pacemaker. And some of the first open heart surgeries Lillehei pioneered were performed in the OR directly above it.
Stu Silberman, the Bakken Museum’s vice president of advancement, believes the future also rests in the hands of the young students across the state that visit the Bakken each year and that the museum reaches through its various programs.
Part of the Bakken’s mission, Silberman said, is to introduce young minds to the wonders of science the museum’s collection contains.
“We want that kindergartner living in a rural part of the state to have the confidence that she can pursue a career in science or engineering or math, and that she might be the next Earl Bakken and invent a medical device we haven’t heard of yet,” Silberman said. “By offering these experiences to young students, we’re actually fulfilling Earl Bakken’s vision of creating future innovators.”
Just one day after delivering his pacemaker to Lillehei, Bakken witnessed his device keeping a young boy alive.
A photo from the Saturday Evening Post depicting the scene is displayed at the lab’s entrance.
“Imagine, Earl walks into the hospital and sees his prototype device keeping a child alive,” Iaizzo said. “He actually got to see that.”
Kowal also noted that Bakken, who died in 2018 at the age of 94, lived long enough to see the design for Micra. But while amazed at its size and sophisticated circuitry, Bakken, however, did not seem overly surprised.
“He dreamed of all of this. So, for him, it was the dream come true,” Kowal said. “He always had the vision that we would eventually get there, it was just a matter of time. And that’s where he was amazing, because he had the vision for these things well before the technical capability to get there even existed.”