FDA Approves Leadless, Single-Chamber Pacemaker System

FDA Approves Leadless, Single-Chamber Pacemaker System

The Meals and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for sufferers with bradycardia.

In a press launch, Abbott stated the system has a novel mapping functionality that permits interventionists implanting the system to measure electrical alerts throughout the coronary heart to find out the right placement earlier than ultimate implantation. Aveir is implanted straight into the correct ventricle through a catheter.

The corporate additionally stated Aveir has a battery life that’s as much as twice so long as different commercially accessible leadless pacemakers when following Worldwide Affiliation for Standardization (ISO) customary settings. And the system may be retrieved if crucial, the press launch stated.

“Leadless pacemakers handle identified problems related to conventional pacemakers,” Rahul Doshi, MD, director of electrophysiology at Honor Well being in Scottsdale, Ariz., stated within the press launch. “As well as, the Aveir leadless pacemaker brings distinctive improvements we’ve been looking for, equivalent to the flexibility to make sure electrical efficiency earlier than we decide to placement.”

Investigators of the LEADLESS II part 2 research reported final yr on what they referred to as “key design enhancements” of the Aveir system in comparison with the primary leadless pacemaker, the discontinued Nanostim. They included a 12% longer battery life, a shorter and wider kind issue, a modified docking button that permits for retrievability, a modified supply system, and an application-specific built-in circuit chip that may help a dual-chamber pacing system sooner or later.

The research reported that 96% of the 200 enrolled sufferers met the first security endpoint of no severe device-related hostile occasions at 6 weeks after implantation. An identical proportion achieved therapeutic pacing and sensing amplitude.

The research additionally reported that interventionists precisely positioned Aveir the primary time or with a single repositioning in 96% of circumstances.

This text initially appeared on MDedge.com, a part of the Medscape Skilled Community.

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