World First: FDA Tick for Dual-Chamber Leadless Pacemaker

Image credit: Abbott

In a world first, a dual-chamber leadless pacemaker has been approved this month by the United States’ Food and Drug Administration (FDA).

Developed by global healthcare giant Abbott, the AVEIR™ pacemaker system is used to treat people with abnormal or slow heart rhythms.

The device is implanted directly into the heart, eliminating the need for cardiac leads as used with traditional pacemakers – and in doing so, reducing potential complications and post-implantation recovery time.

Backing the FDA approval was clinical research shared by the company earlier this year, with findings including a 98.3 percent implant success rate and over 97 percent of patients presenting successful atrioventricular synchrony when implanted with the device.

With most patients requiring a pacemaker also in need of pacing in two of the heart chambers, Abbott said the FDA greenlight meant significantly greater access to such technology for millions of people.

“Leadless pacemakers have been limited to a single chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge – until now,” said Abbott executive, Randel Woodgrift in a press statement.

“Our team of dedicated scientists and engineers solved one of medtech’s complex challenges in treating abnormal heart rhythms with the AVEIR pacemaker, a tiny device packed with powerful technology.”

For more information, check out the full announcement from Abbott.