Ohio Doctors recently implanted a tiny pacemaker in a Columbus woman. The surgery was part of a worldwide clinical trial to test the safety and efficacy of small, leadless heart pacemaker.
What's more is that the implant doesn't require a large incision. The wireless device can be inserted using a catheter and attached to the muscles in the heart.
The novel surgery took place at Ohio State's Richard M. Ross Heart Hospital. The Micra Transcatheter Pacing System (TPS) is made by Medtronic.
The new device is about one-tenth of the size of a conventional pacemaker. Medtronic had earlier said that their technology is "game-changing." The market for such itsy bitsy pacemakers is expected to grow to $5 billion by 2015, the company said.
"With this investigational device, the battery, the pacing electrodes, everything is in a little piece of metal sitting inside the heart. We believe that will eliminate a lot of risk for infection and complications," said Dr. John Hummel, a cardiologist and principal investigator of the trial at Ohio State.
Researchers are currently testing the device in patients with bradycardia who need single chamber ventricular pacing, according to a news release.
Patients with the condition suffer from irregular heart rhythm. Their heart pumps blood slowly, which results in feelings of dizziness and fainting.
Mary Lou Trejo of Columbus, 77, is a former librarian and suffered from atrial fibrillation for several years. Doctors prescribed medications to restore normal heart rhythm. However, none of the treatments worked and she underwent the pacemaker surgery.
"The new pacemaker sounded so simple, and I have always thought research is important, so I thought this is a way I could contribute," Trejo said.
Doctors hope that the device works as intended. Its approval could make pacemaker placement surgeries less invasive and more efficient.
"I think this could be a significant development in pacing procedures. This could cut our procedure time by more than half," said Dr. Ralph Augostini, a cardiologist at Ohio State.
Around 780 patients in 50 centers worldwide will take part in the clinical trial, which is being funded by Medtronic.