World’s First Dual-Chamber Leadless Pacemaker Announced By Abbott After Pivotal Trial

As part of its pivotal AVEIR DR i2i™ clinical study, Abbott announced today the world’s first dual-chamber leadless pacemaker implants. It is the first time around the world that Abbott’s investigational AveirTM dual-chamber pacemaker has been implanted using leadless pacing technology, representing a milestone for this kind of operation.

Slower-than-normal heartbeats may be treated with a pacemaker, which is a small battery-powered device implanted in the chest that transmits electrical impulses to the heart through thin wires, called cardiac leads, causing the heart muscle to contract, thereby hopefully restoring a normal heartbeat.

In contrast to traditional pacemakers, leadless pacemakers prevent the need for cardiac leads by being implanted directly into the heart through a minimally invasive catheter-based process. Leadless pacemakers regulate heart rate like traditional pacemakers, but they are less invasive and offer a shorter recovery time, due to the reduced lead-related complications. However, historically, leadless pacing options have been limited to single-chamber devices, as the synchronization of two leadless pacemakers has proved to be difficult to achieve.

Abbott solved this problem by creating the company’s innovative “i2i technology”, which provides beat-by-beat communication between a pair of leadless pacemakers, one positioned inside the right ventricle, and the other positioned in the right atrium. This technology has been designed to synchronise the heart rate between chambers, allowing for true dual-chamber leadless pacing.

Dr. Daniel J Cantillon said: “The first-in-human implant of a dual-chamber leadless pacemaker is a major clinical milestone that will open up new possibilities for patients requiring pacing support. Abbott has designed a device capable of treating these patients, and we’re excited to see this technology advance patient care.” Randel Woodgriff, Abbott’s senior vice president of their cardiac rhythm management business, had this to say: “The Aveir DR dual-chamber leadless pacemaker builds upon our Aveir VR single-chamber leadless platform, and we believe that once approved these systems have the potential to change the way doctors approach the treatment of abnormal heart rhythms. The involvement of world-class heart institutions in this study reinforces that the innovations we are developing are exactly the kind of advancements physicians around the world want for their patients.” Dr. Reinoud Knops added: “As leadless pacing technology has evolved, we’ve always viewed dual chamber leadless technology as a therapy evolution that would have a dramatic impact on more patients – but a technology that was going to be very challenging to develop. That we’ve reached this point in time where dual chamber pacing without leads has become a reality is a monumental moment for modern medicine.” It has been Abbott’s focus to drive the development of leadless pacing technology with the aim of improving care for more patients fighting abnormal heart rhythms, and Abbott’s single-chamber leadless pacemaker, Aveir VR, successfully met the primary endpoints of its pivotal trial, marking the latest milestone for the company.

© Abbott Laboratories

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