KANSAS CITY, Mo. -- The world's tiniest pacemaker has received FDA approval. It's the first pacemaker with no wires, and the first that's not implanted just under the skin. This one goes directly into the heart.
Rina DeBarthe of Olathe used to have trouble taking more than a dozen steps at a time.
"I'd be so weak. I had to sit down," DeBarthe said.
Her heart was beating too slowly. She couldn't get a standard pacemaker because of issues related to dialysis for kidney failure. But DeBarthe learned she could get the world's tiniest pacemaker at Saint Luke's Hospital.
"I said okay. I'm for anything that could help me," DeBarthe said.
It's called Micra and it's about one-tenth the size of standard models. Unlike them, it isn't placed just under the skin with a wire connected to the heart. Instead, a small incision is made in the inner thigh. The doctor threads a sheath up into the heart to deliver the pacemaker which has little prongs or tines to grip the tissue.
"You release it and the tines go out into the tissue and it locks it into place," said Dr. Alan Wimmer, who performed DeBarthe's procedure.
It grips the tissue of the right ventricle.
"There are a lot of patients out there that need pacing and only in that one chamber, and so many of them will be candidates for this," he added.
DeBarthe got Micra in January as part of research. It won FDA approval last month.
She went home the day after the procedure and says with the new, tiny pacemaker, her energy level immediately jumped.
"I feel so much better," she said.
She'd like to have another Micra.
"So I could wear it and tell people about it," she said.
Micra is expected to cost more than standard pacemakers. Initially, many insurers may not cover it.