Though the FDA approval for Abbott’s first leadless pacemaker comes several years after its competitor Medtronic achieved the feat, the devicemaker aims to up the tempo.
Like its peers in the field, the newly approved Aveir VR single-chamber implant is aimed at speeding up a slow heart rhythm, but it offers a longer battery life, a pre-placement mapping system and the fact that it can be easily removed if needed, according to Abbott.
Before the device is implanted, Abbott’s system assesses the heart’s electrical signals to determine the device’s ideal placement—a feature that no other pacemaker offers, the company claims.
From there, the Aveir device is placed in the right ventricle of the heart in a minimally invasive procedure that uses only a catheter sent through the blood vessels, rather than requiring open incisions into the chest. It’s also the first leadless pacemaker designed to be easily removable as a patient’s therapy needs change or when the device needs to be replaced—and can be done so in the same minimally invasive method used to put it in place.
The Aveir system delivers electrical pulses as it detects a slower-than-normal heart rate, rather than sending out a constant stream of pulses. When programmed with standard settings, the pacemaker’s battery can last up to two times longer than other leadless pacemakers currently on the market, Abbott said.
In study results shared last year, the Aveir VR was successfully implanted in 98% of patients, and about 96% of them achieved the therapeutic pacing threshold, sensing amplitude and safety endpoints by six weeks after the procedure. Additionally, the pre-placement mapping technology helped physicians implant the devices in the correct location on either the first or second try in 96% of the cases.
“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,” Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, said in a statement. “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.
Next up on that docket is a dual-chamber version of the leadless pacemaker. The Aveir DR device comprises two wireless, synchronized pacemakers that are implanted in the right ventricle and right atrium of the heart for additional rhythmic support. Like its single-chamber sibling, the Aveir DR is also meant to be easily placed and replaced as needed.
The first of these systems was implanted earlier this year as part of a clinical trial that plans to recruit up to 550 patients from as many as 80 sites around the world.