Micro Pacing System Cleared by FDA

A small, dual-chamber rate-responsive pacemaker has been cleared by the U.S. Food and Drug Administration (FDA). The device is the product of St. Jude Medical (St. Paul, MN, USA), which states that it is the world's smallest dual-chamber pacemaker--about 30% smaller than other dual-chamber devices.

Called the Integrity Micro AutoCapture Pacing System, the pacemaker incorporates St. Jude's proprietary autocapture pacing feature, which monitors for capture on a beat-by-beat basis and provides a high-output, backup safety pulse in the event of noncapture, while continuously and automatically adapting output slightly above the patient's threshold. By delivering the lowest possible energy output required to capture, the pacemaker offers a projected longevity of more than six years. The device is available in both dual-chamber and single-chamber models.

"This device provides the ability to manage and adapt to numerous patient conditions, which are often in flux. It is rare to encounter such a small pulse generator that doesn't yield any compromise in therapeutic efficiency,” said Dr. Michael Antimisiaris, director of the electrophysiology lab at New York Hospital Medical Center of Queens (Flushing, NY, USA). Dr. Antimisiaris performed the first U.S. implant of the new pacemaker in December. The recipient was an 80 year-old male with complete heart block.



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