The US Food and Drug Administration (FDA) has granted approval for Abbott’s Aveir single-chamber (VR) leadless pacemaker to treat patients in the country with slow heart rhythms.
The new pacemaker has been designed to be directly implanted inside the right ventricle of the heart through a minimally invasive procedure and without the need for an incision in the chest.
It has a unique mapping capability that allows physicians to measure electrical signals in the heart.
The device is claimed to be the only leadless pacemaker in the world that can determine the correct positioning of the device prior to final implantation.
Abbott stated that the Aveir VR leadless pacemaker comes with an enhanced projected battery life, which can be up to two times longer than other commercially available leadless pacemakers.
Additionally, the device has been designed to be retrieved if the therapy needs an update or if it needs replacement.
Abbott cardiac rhythm management senior vice-president Randel Woodgrift said: “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.
“Our goal is to continue to build on the success of Aveir to provide more first-of-their-kind products in the future, revolutionising how abnormal heart rhythms are treated.”
The regulatory approval is supported by data obtained from the international Phase II LEADLESS II investigational device exemption (IDE) study, which assessed the Aveir VR leadless pacemaker in certain abnormal heart rhythms patients.
In February, Abbott received US FDA approval for its CardioMEMS HF System to support patients with earlier-stage heart failure.