Abbott picks up the pace with FDA approval of removable, long-lasting leadless pacemaker

Abbott picks up the pace with FDA approval of removable, long-lasting leadless pacemaker

While Abbott has FDA approval for the first lead-free pacemaker a few years after rival Medtronic’s performance, the device maker wants to pick up the pace.

Like their field counterparts, the recently approved Aveir VR one-room implant aims to speed up a slow heart rate, but offers longer battery life, a pre-positioning mapping system, and the fact that it can be easily removed, easily if necessary, then. Abbot.

Before implanting a device, the Abbott system evaluates electrical signals from the core to determine the ideal placement of the device, a feature that no other pacemaker offers, according to the company.

From there, the Aveiro device is inserted into the right ventricle of the heart with a minimally invasive procedure that uses only a catheter that passes through the blood vessels, rather than requiring open incisions in the sinus. It is also the first lead-free blower designed to be easily removed when patient treatment changes or the device needs to be replaced and can be performed using the same minimally invasive method used for the patient.

The Aveir Real System provides electricity because it senses a slower heart rate than the normal heart rate, rather than sending out a constant real current. When programmed with preset settings, the blower battery can last up to twice as long as other non-contact pacemakers currently on the market, Abbott said.

In the results of a study published last year, Aveir VR was successfully implanted in 98% of patients, with approximately 96% reaching the therapeutic packaging threshold, detection width, and safety parameters at six weeks. after the procedure. Additionally, pre-positioning mapping technology helped clinicians implant devices in the correct position during the first or second trial in 96% of cases.

“The Aveir VR touchless pacemaker is designed to make implantation and removal processes as smooth as possible for clinicians and to offer enhancements to existing options,” said Randel Woodgrift, senior vice president of Abbott’s heart rhythm management business, in a statement. “Our goal is to continue building Aveir’s success in providing more unique products in the future that will revolutionize the treatment of cardiac arrhythmias.

First on the list is a two-chamber version of the lead-free accelerator. The Aveir DR device consists of two synchronous wireless pacemakers implanted in the right ventricle and right atrium of the heart for additional rhythmic support. Like its one-room sibling, Aveiro DR should be easy to install and replace if needed.

The first of these systems was implanted earlier this year in a clinical trial that will enroll up to 550 patients at up to 80 sites worldwide.

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