Abbott wins CE mark for dual-chamber leadless pacemaker

Dive Brief:

Abbott said Thursday it has received a CE mark for its dual-chamber leadless pacemaker, clearing the company to start selling the system in Europe.
The Aveir DR system has two synchronized leadless pacemakers, one for the right atrium and another for the right ventricle, setting it apart from single-chamber devices such as Medtronic’s Micra.
Abbott has identified the device, which won approval in the U.S. in 2023, as a product that can help its cardiac rhythm management business achieve sales growth of at least around 6% to 7%.

Dive Insight:

Abbott named Aveir as a driver of the 7.5% organic sales growth reported by its rhythm management unit in the first quarter. CEO Robert Ford said on an earnings call in April that Aveir “rapidly captured market share” in the single-chamber pacing segment after its U.S. authorization last year. Ford cited the longer-lasting battery and ability to upgrade from a single atrial or ventricular device to a combination.

Abbott currently has about a 50% market share in the U.S. for single-chamber pacing, Ford said. The company is now working to grow sales of the dual-chamber device. Abbott saw “a nice ... ramp-up over this first quarter,” the CEO added, and believes further growth is possible as more physicians get trained to use Aveir DR.

“It's a completely different procedure ... If you think about how these devices have been implanted, this is probably the first time in like 30 years you have a real meaningful change on how this is done,” Ford said. “Our focus here is really getting great clinical results, a real thoughtful approach here about opening new centers and training.”

Abbott now has clearance to expand commercialization of Aveir DR to the European Union and other markets that accept CE marks. The company obtained a CE mark for its single-chamber Aveir device in 2023.

The progress has helped Abbott bounce back from problems with its older Nanostim device, use of which was halted after a part detached, and established the company as a rival to Medtronic in the leadless pacemaker market.