Abbott’s Aveir Leadless Pacemaker Evaluated in IDE Pivotal Trial

November 12, 2021—Abbott announced late-breaking data from the global Leadless II investigational device exemption (IDE) study that is evaluating the company’s investigational Aveir leadless pacemaker in patients with certain abnormal heart rhythms. The data from the IDE study have been submitted to the FDA as the device is being evaluated for approval in the United States. The Aveir device is not yet commercially available.

The prospective, nonrandomized, multicenter Leadless II IDE study is designed to evaluate the clinical safety and efficacy of the Aveir leadless pacemaker in patients indicated for a VVI(R) ventricular demand pacing pacemaker. For the primary endpoint analyses, all patients were followed for 6 weeks postimplant to evaluate potentially serious adverse device effects. During this time, efficacy was measured as acceptable pacing capture threshold (≤ 2.0 V at 0.4 msec) and sensing amplitude (R wave ≥ 5.0 mV, or a value equal to or greater than the value at implantation).

According to Abbott, the data show that the Aveir device met its prespecified primary endpoints and suggest that, when approved, the Aveir system could offer new benefits for patients who require the use of a pacemaker to treat slow heart rhythms.

The findings were presented in a late-breaking session at the annual scientific sessions of APHRS 2021, the 14th Asia Pacific Heart Rhythm Society scientific session held November 11-14 in Suzhou, China. Simultaneously, the findings were published online as a Research Letter by Vivek Y. Reddy, MD, et al in the Journal of the American College of Cardiology: Clinical Electrophysiology.

Dr. Reddy, who is Helmsley Trust Professor of Medicine and Director of Cardiac Arrhythmia Services at Mount Sinai Hospital in New York, New York, commented in the company’s announcement, “The new Aveir pacing system holds the potential to help us advance treatment for patients who need a pacemaker but where physicians are concerned about more invasive surgery or in circumstances where we believe a patient’s therapy needs may change in the future and where retrievability will be a critical device feature.”

Abbott stated that under the Leadless II trial design, primary safety and efficacy endpoints were analyzed in 200 patients enrolled at 43 centers in the United States, Canada, and Europe. Patients were followed for 6 weeks. Results of the study showed:

• Successful implant with the Aveir leadless pacemaker occurred in 98% of patients.
• At 6 weeks postimplant, 96% of patients met the safety endpoint of no serious adverse device effects.
• At 6 weeks, 95.9% of patients achieved the efficacy endpoint of acceptable therapy delivered to the patient (ie, the therapeutic pacing threshold and sensing amplitude).
• Physicians were able to accurately position the device either the first time or with a single repositioning in 96% of clinical cases.