FDA Gives The Okay For Abbott’s New Minimally Invasive Pacemaker

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FDA Gives The Okay For Abbott’s New Minimally Invasive Pacemaker
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On Wednesday, medtech giant Abbott announced that its new leadless pacemaker system, Aveir DR, has been approved by the FDA. This is the first time the FDA has given a thumbs up to a device of this type for two different chambers of the heart.

in March 2022. Both of these products, however, only work in a single chamber of the heart. About 80% of the patients that require a pacemaker need shocks in two cardiac chambers in order to keep the desired heart rhythm.

Abbott engineers solved this with a proprietary system the company markets as “i2i.” The communication system works by transmitting high frequency electric pulses that take advantage of the electric conductivity of blood to deliver the signal. “So with this incredibly efficient, conducted telemetry, we can get reasonable battery longevity ease, despite the fact that the devices are tiny, and they're communicating with each other within every heartbeat,” explains Ganz.

“What’s amazing about this is the ability for the two devices, the one in the top and bottom chambers, to communicate with each other,” says Vivek Reddy, an author of the study and electrophysiologist at Mt. Sinai whose lab receives grant support from Abbott. Another aspect of the clinical study he highlights is that there was only one patient who experienced a serious complication in implanting the device out of the 295 patients.

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