Medtronic developing new mini pacemakerby Martin Moylan, Minnesota Public Radio
St. Paul, Minn. — Medtronic believes it can help sales grow by making some long-standing products shrink, including a new mini pacemaker about the size and shape of large vitamin capsule.
The device could could be implanted through a vein in a patient's leg -- and go right inside the heart.
The company has been developing the pacemaker for about a year now.
It looks a cross between a battery and a beetle, with bug-like antenna sweeping back from one end.
The technology has yet to be tested in animals -- never mind humans. It's about five years away from being ready for market, if it's approved by the Food and Drug Administration.
But Medtronic figures the device is viable and will greatly expand the market for pacemakers in nations such as China, Russia, India and Brazil. Medtronic representatives say the device's size will make it easier and cheaper to implant in patients.
"Think about being able to have a device that you can implant easily in countries where they aren't used to having pacemakers," said Dr. David Steinhaus, chief medical officer for Medtronic's cardiac rhythm disease management division. "And now all of a sudden you have this life-saving therapy."
People in the U.S.and rest of the developed world who need pacemakers to restore normal heart rhythms generally get them, but that's not the case for billions of people around the globe, Steinhaus said.
Steinhaus says the new device will not require the same level of medical expertise needed to implant a traditional pacemaker.
Currently, an electrophysiologist must open a small pocket in a patient's upper chest, where the device is housed, and then connecting wires are threaded through veins into the heart.
Steinhaus said countries such as India have relatively few doctors qualified to implant traditional pacemakers.
The procedure for implanting Medtronic's mini-pacemaker will be simpler and easier, he said.
"We would go through perhaps the femoral vein, which is the vein in the leg," he said. "We would run the catheter up into the heart and deliver this capsule, which would then have a fixation mechanism -- a way to stick right inside the heart -- and it would stick inside the heart, stay there and deliver its pulses as necessary.">
Steinhaus expects there could be strong interest in the smaller pacemaker in the U.S as well, as the device would not leave a telltale scar and bump on a patient's chest, as traditional pacemakers do.
"When you have a pacemaker, even though it's relatively small, it's still something you look at every day when you look at yourself in the mirror," he said. "And you can imagine if we put it right inside your heart, like a stent, you kind of forget about it. It's just there to help you when you need it. And you don't have to worry about it otherwise."
Advanced electronics allow for the device to be so small, and Medtronic says it should meet the needs of many, perhaps most, patients. But some will require bigger, more sophisticated devices.
The battery for the mini-pacemaker will last about as long as existing units, about seven years. If a battery is running out of power, a new pacemaker would be implanted. The old one would not come out.
Although Medtronic's technology is new, the idea is not.
"There's always been a great deal of interest in eliminating the wire that goes into the heart from the pacemaker that's under the skin," said Dr. Robert Hauser, the senior consulting cardiologist at the Minneapolis Heart Institute.
He said the pacemaker Medtronic is developing has great potential.
"It simplifies pacing in the sense it eliminates that wire that goes through the vein into the heart," he said.
But, he said, "Medtronic is not the only company working on this."
Hauser has been working with companies developing a similar product. He wouldn't name them.
Likely competitors could include St. Jude Medical and Boston Scientific -- both with major operations in Minnesota. Neither company could be reached for comment.
Medtronic expects to begin animal trials of the mini-pacemaker next year. Human trials are expected in about three years.
- All Things Considered, 11/01/2010, 5:50 p.m.