Abbott’s Aveir VR Leadless Pacemaker OK’ed for Slow Heart Rhythms

Abbott has earned U.S. Food and Drug Administration (FDA) approval for its Aveir single-chamber (VR) leadless pacemaker to treat patients with slow heart rhythms.
 
Implanted directly inside the right ventricle via a minimally invasive procedure, Aveir treats slower-than-normal heart rates. Leadless pacemakers do not need a chest incision to implant the device or cardiac leads.
 
Aveir’s unique mapping function helps measure the heart’s electrical signals to determine correct implant placement before the operation. According to Abbott, it has a projected battery life of up two times longer than other available leadless pacemakers when using ISO standard settings.
 
Aveir is also the only leadless pacemaker designed to be retrieved if therapy needs change.
 
“The Aveir leadless pacemaker offers an exciting option for the treatment of people with cardiac arrhythmias. Leadless pacemakers address known complications associated with traditional pacemakers. In addition, the Aveir leadless pacemaker brings unique innovations we’ve been seeking, such as the ability to ensure electrical performance before we commit to placement,” Rahul Doshi, MD, Director of Electrophysiology, Honor Health told the press. “Abbott’s leadless pacemaker addresses the need for a single-chamber device that accommodates any therapy path for a patient through Aveir’s retrieval capability and extended battery longevity.”
 
The LEADLESS II phase 2 IDE study supported this approval, showing Aveir VR met primary endpoints for patients with certain arrhythmias.
 
“The Aveir VR leadless pacemaker was designed to make the implantation and retrieval processes as seamless as possible for physicians and provide improvements over existing options,” said Randel Woodgrift, senior vice president, Cardiac Rhythm Management, Abbott. “Our goal is to continue to build on the success of Aveir to provide more first-of-their-kind products in the future, revolutionizing how abnormal heart rhythms are treated.”