Abbott has reported positive data from the Leadless II IDE trial, which assessed its Aveir leadless pacemaker for the treatment of patients with certain types of abnormal heartbeats.
The Aveir system is claimed to be the only leadless pacemaker in the world designed to be retrievable when the system either needs to be replaced or if a patient’s course of therapy requires alteration.
The Leadless II IDE trial is a multicentre, non-randomised, prospective study to assess the device’s efficacy and safety in patients indicated for a ventricular pacing on-demand or VVI(R), which stimulates heartbeats only if the rate goes below the required level.
The new, late-breaking data demonstrates that the device met the pre-specified primary safety and efficacy goals.
The study evaluated 200 subjects enrolled in 43 centres in the US and Canada. They were monitored for six weeks after implantation.
Results of the trial showed that the pacemaker was implanted successfully in 98% of the patients, being precisely positioned either the first time or with a single repositioning in 96% of cases.
Additionally, 96% of patients saw no serious adverse effects at six weeks of implantation and 95.9% achieved the efficacy of acceptable treatment.
Abbott cardiac rhythm management senior vice-president Randel Woodgrift said: “As we developed the Aveir leadless pacemaker platform, our fundamental guiding principle was to design a device with extended battery life that could be retrievable, expandable to incorporate future innovation and provide improved patient outcomes with a minimally-invasive implant procedure.
“The results of the Leadless II study are a strong indicator that once the device is approved, the Aveir system can help physicians manage the care of patients with certain abnormal heart rhythms.”
The company presented the findings at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS).
The data has also been submitted to the US Food and Drug Administration (FDA) for approval.