FDA approves smallest pacemaker, developed by Medtronic

The Federal Drug Administration has approved the world’s smallest pacemaker for patients in the U.S. The Medtronic Micra Transcatheter Pacing System is one-tenth the size of traditional devices. This new technology is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart.

Ron Weeks lives with the new device, which is about the size of a large vitamin. He was told last April he had an irregular heartbeat. “To quote the doctor, he said, ‘Your heart beat is all over the place,'” Weeks said. His doctor was part of a global clinical trial that allowed patients to test miniaturized pacing technology. Unlike traditional pacemakers, the Micra does not require leads or a surgical pocket under the skin.

“They actually go through a vein in the groin, and they, with a catheter, take this device into the heart and attach it into the heat and then pull the catheter out and it’s there,” Weeks said. Despite its size, the Micra’s pacing system provides patients with the most advanced pacing technology available. Once inside the heart, it delivers electrical pulses when needed to pace the heart.

“I think it’s nothing short of incredible that this therapy is being developed,” said Dr. John Hummel. He believes the miniature pacemaker is going to reduce device-related infections. “We are looking at the beginning of the future,” Hummel said. “We will no longer pace the heart the way we have for the past 20 to 30 years.” The device responds to patients’ activity levels by automatically adjusting therapy.

For Weeks, making the decision to go with new technology has helped him keep moving without skipping a beat. “I felt a lot better after the procedure,” Weeks said. The trial enrolled more than 700 patients and monitored them remotely. The Micra device is expected to be available to others later this year.

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