Dual-chamber leadless pacemaker system implanted in first patient

MedTech News: The first patient has been implanted with a novel dual-chamber leadless pacemaker system in a pivotal clinical trial.

Abbott’s Aveir DR i2i dual-chamber leadless pacemaker represents a significant technological milestone for leadless pacing systems.

Traditional pacemaker systems have included a separate power generator placed under the skin near the collarbone, which then connects to the heart with a series of wires. But a new generation of leadless pacemakers, smaller in size, are implanted inside the heart and anchored directly to the muscle wall in a less invasive procedure.

Until now, leadless pacing options have been limited to single-chamber devices because synchronisation of two leadless pacemakers has been highly difficult to achieve. Abbott solved for this challenge by designing the company’s innovative “i2i technology” to provide beat-by-beat communication between two leadless pacemakers, one positioned in the right ventricle and one positioned in the right atrium. This technology is designed to regulate the heart rate synchronously between chambers and allow for true dual-chamber leadless pacing.

“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,” said Dr Daniel Cantillon, clinical trial steering committee co-chair and Associate Section Head and Research Director of Cardiac Electrophysiology and Pacing, Cleveland Clinic.

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“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,” said Dr Reinoud Knops, clinical trial steering committee co-chair and Department of Cardiology and Electrophysiology, Amsterdam University Medical Centre, Netherlands. “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.”

Because nearly 80% of people who receive a pacemaker need a dual-chamber option to pace both chambers on the right side of the heart, Aveir DR has been designed to address a critical need for these patients. Abbott also designed the Aveir DR leadless pacemaker to be retrievable, so the system can be replaced or retrieved as therapy needs evolve. The Aveir DR system is designed to provide real-time mapping capability so physicians can assess therapy delivery and reposition the device before implant during a patient’s procedure. 

“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,” said Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business. “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.”

Boston Scientific’s two-device approach combines a leadless pacemaker with an implantable cardioverter defibrillator aims to deliver either pacing support when the heart beats too slow or a shock when it beats too fast.

Medtronic has delivered real-world data on its own leadless pacemaker, the Micra, showing that it led to fewer complications compared to wired cardiac implants over two years. A newer version, the Micra AV, was FDA approved in January 2020 and TGA registered in October 2021.

Abbott’s Aveir DR i2i study is a prospective, international, single-arm study with plans to enrol up to 550 patients from up to 80 sites in the U.S., Canada, Europe and Asia-Pacific, with patients to be followed for a minimum of 12 months post-implant.