NDSU Team Succeeds in New Pacemaker Technology
Post Date: Apr 21 2015
By The Daily Republic
An eclectic team of medical personnel, animal experts and electrical engineering professors and graduate students recently gathered on the North Dakota State University campus to test a prototype for a cardiac pacemaker that works without wires or batteries.
The group was able to "pace" a sheep's heart by transmitting radio frequency energy--much like what comes from your cellphone--from an antenna into a tiny microprocessor in the sheep, without contact with the animal.
"A lot of things in medicine are going to get rid of wires, get rid of batteries," said Dan Ewert, a professor in NDSU's Electrical Engineering department, who led the experiment.
"It's an exciting development," Ewert said.
According to the Journal of The American College of Cardiology, 2.9 million Americans received permanent pacemakers between 1993 and 2009, and the number continues to grow steadily.
They're often needed in patients who have a slower than normal heart rate or have a problem with the heart's electrical system.
The weak link in current pacemaker technology is the wires or leads going from the pacemaker into the veins of the heart.
"Over time, if they break down, we have to replace them," said Dr. Christopher Pierce, a cardiologist and electrophysiology specialist at Sanford Health in Fargo, who was not involved in the recent experiment.
Pierce said sometimes the wires themselves become infected and have to be removed through a laser procedure.
Ewert and an electrical engineering faculty colleague, Ben Braaten, have obtained a patent on their wireless, battery-less technology through NDSU and together formed Krisara Engineering in an effort to establish a start-up company in the valley.
Despite the successes, Ewert said the two have so far been unable to make that leap, so the technology "sits" in the NDSU Research Foundation.
The technology's incubation
The two first teamed up in 2009, when Ewert hired Braaten at NDSU for his acumen with radio frequency energy. As a chair of the electrical engineering department at the time, Ewert said he wanted faculty and students to work together on unique ideas and develop new things--then "plow that back into the state's economic development."
Ewert and others began assembling "scholar teams" and "super teams" of people from inside and outside of NDSU to brainstorm the technology further.
The process of bringing a new medical device to the market is a long and expensive one--taking it from concept to product development to human trials--before it can be approved by the Food and Drug Administration.
At one point down the line, Ewert said the NDSU-borne technology caught the interest of one of the biggest medical technology companies in the country--but for a number of reasons which he didn't want to disclose, a partnership never came to fruition.
However, the two applied for and secured a venture grant from the North Dakota Department of Commerce, designed to help move university-developed technology into the marketplace.
"Dan took the biomedical side--the compliance side--getting the animal ready, and I took the technology side--built the prototypes, looked at the complications for safe power and worked on the procedure to implant the electrodes," said Braaten, assistant professor in electrical engineering.
The grant helped propel the technology to where it is now.
"Without that money, this would still be on paper," said Ewert.
The implantation of the pacemaker took place on the NDSU campus on March 19, with a retired surgeon from the VA Medical Center leading the surgical aspect of the experiment. Dr. Mark Jensen has a keen, personal interest in the project. He was born with a rare heart defect, has a family history of heart disease and is due for a pacemaker himself due to an abnormally slow heart rate.
He knows wireless technology is the future for pacemakers.
"I want to make this thing work!" Jensen said in an interview with The Forum in February.
Joining Jensen was an operating room nurse, veterinarians, engineers and NDSU animal handling specialists.
At first, things looked bleak.
"When we started out, we had 2 percent efficiency," said Sajid Asif, an NDSU graduate student who was part of the project.
But after working around the clock on a redesign, the group tried again.
"The energy is coming from outside the body, and we're able to pace the heart that's existing inside that sheep--this was the first time that we did it," said Ewert.
The group has a ticker-type strip to show--almost a souvenir of their work.
"What you see on the left here is the heart normally beating," said Jared Hansen, another NDSU grad student, as he pointed to the paper strip.
"Then when we start pacing, you see these large spikes," he said.
The second part of their experiment involved fashioning a smaller, flexible antenna-- one that could be attached to the skin.
"Something closer to what you might wear," said Braaten.
The pacemaker electrodes themselves will be made smaller as well, with as many as six in all being embedded in the outside of the heart.
"Similar to the smallest Tylenol gelcaps--and once we show that in an animal model, the next step is to go to human testing," said Braaten.
The next level
Human testing of a medical device requires a huge financial investment.
Industry giants Medtronic and St. Jude Medical Center, both Minnesota-based companies, both have wireless pacemakers currently in use in human clinical trials, mainly outside of the U.S.
But unlike the NDSU prototype, each contains batteries and each is placed in a single chamber of the heart, which limits the type of heart problems it can remedy.
Ewert thinks those factors are what make the NDSU technology better.
No matter which technology catches on, it appears wires are on the way out, and Dr. Pierce, who's placed thousands of pacemakers over the years and removes broken pacemaker wires from patients every few weeks, thinks that will be a good thing.
"It would reduce the bulk of foreign bodies that can get infected or block up veins," said Pierce.
Ewert and Braaten are chomping at the bit to take their version of the technology to the next step.
"We have the team assembled, we have the technology, we're where we need to be," Ewert said.
He said it's an indication of the sheer level of talent that exists at NDSU and in the state of North Dakota.
"There's only a handful of people in the world who can do what these guys are doing," Ewert said, "and we just happen to have them here."
NDSU Team Succeeds in New Pacemaker Technology - The Daily Republic