Dr. Reddy presented the one-year LEADLESS study data findings during his late-breaking clinical trial presentation on
The LEADLESS study's long-term follow-up has evaluated 32 patients with a slowed heartbeat, bradycardia, who successfully received
The findings, which assessed device performance and patient outcomes through 12-months of follow-up, show pacing thresholds (0.43 volts) and sensing (10.32 mV) of the leadless pacemaker device are equivalent to those in traditional pacemakers. In addition, there was no experience of infections or failure to sense, pace, or communicate with the pacemaker.
"This is the first time we've seen one-year follow-up data for this innovative, wireless cardiac pacing technology and our results show the leadless pacemaker is comparable to traditional pacemakers," Dr.
"Our latest findings further support the promising performance and safety of this minimally-invasive, non-surgical pacing device. More long-term follow-up of these LEADLESS study patients will further our understanding of the potential advantages, benefits, and complication risks of leadless pacemaker technology, along with additional ongoing, larger trials," he said.
In February, Dr. Reddy was the first to implant the leadless pacemaker in
The miniature-sized, leadless cardiac pacemaker is placed directly inside a patient's heart without surgery during a catheter-guided procedure through the groin via the femoral vein.
The device, resembling a tiny, metal silver tube and smaller than a triple-A battery, is only a few centimeters in length, making it less than ten percent the size of a traditional pacemaker.
It works by closely monitoring the heart's electrical rhythms and if the heart beat is too slow it provides electrical stimulation therapy to regulate it. (ANI)
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