Tiny Pacemaker Receives FDA Approval
NEW YORK (CBSNewYork) -- A pacemaker has to have a sensor to tell when the heartbeat is going wrong, a generator to deliver electricity to normalize the rhythm and a battery to power all that. You can now get all that in something the size of a big vitamin tablet.
As CBS2's Dr. Max Gomez reported, Janet Mercel was a normal, active young woman, played tennis and hiked -- and then she started fainting.
"Went from once a month towards, in the last two years, once a week, and then in the last six months almost daily," said Mercel, a heart arrhythm patient.
Mercel's fainting came on without warning -- and nearly killed her on a number of occasions.
"I wrapped my car around a tree once, crashed it a couple of other times and fell in front of some subway platforms and almost fell into the rails a couple of times," she said.
Her problem was a heartbeat that was too slow, sometimes as low as 20 or 30 beats per minute.
The standard treatment for that problem, called bradycardia, is a pacemaker. That involves implanting the battery and generator under the skin and running electrical leads into the heart, which have been known to break.
"So what would be better than to combine that generator, all the leads, all the power, all the function into a small, little device that can be implanted in the heart without a surgical incision or all of that hardware?" said Dr. Larry Chinitz of NYU Langone Medical Center.
And that's exactly what has been done. The Micra is tiny and completely self-contained. It's threaded into the heart through a vein in the groin, similar to a heart catheterization. It's then hooked in the muscle of the heart where it monitors the heart rhythm.
The Micra was approved by the Food and Drug Administration on Thursday. The device is programmable and removable if need be.
"Longevity will be similar to standard pacemakers," Chinitz said. "So currently we have an estimation of in excess of 10 years."
Mercel recently saw the Micra for the first time since she had one implanted 18 months ago in a clinical trial.
"I was not expecting to see this little thing," she said.
"I'm doing well. I've been doing very well. I haven't fainted once," she said, adding she feels healthier and more clear-headed.
