A new pacemaker that is smaller than a AAA battery and contains no lead wires just cleared a major administrative hurdle and could soon be an option for patients with slow or abnormal heart rhythms.
The device, produced by tech company Abbott, received approval from the US Food and Drug Administration, the company announced Wednesday.
The leadless pacemaker, AVEIR, provides a “new, minimally invasive option” that will “revolutionize care,” the company said in a statement.
Currently, 3 million Americans live with pacemakers, 70% of whom are adults age 65 years or older. The majority of pacemaker users require devices in both chambers of the heart.
Abbott had recently announced that clinical trials for AVEIR proved successful, in which 300 patients internationally were fitted and monitored with the equipment for several months.
The company has projected that, following the FDA approval, AVEIR could be made available later this year.
“Leadless pacemakers have been limited to a single chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge — until now,” said Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business. “Our team of dedicated scientists and engineers solved one of medical tech’s complex challenges.”
In addition to technology aimed at treating heart disease, preemptive monitoring of patients with heart conditions continues to be an important focus of research.
A recent study from iRhythm showed that its wearable patch, Zio, monitors arrhythmias and helped create better health outcomes for patients who used it for up to two weeks at a time.
