Abbott Secures CE Mark for Dual-Chamber Leadless Pacemaker

Release date:2024-06-11 Source: Author: Nick Paul Taylor

### Dive Brief:


Abbott announced on Thursday that it has received a CE mark for its dual-chamber leadless pacemaker, allowing the company to begin selling the system in Europe. The Aveir DR system is distinctive due to its two synchronized leadless pacemakers, one for the right atrium and another for the right ventricle, unlike single-chamber devices like Medtronic’s Micra. Abbott expects this device, which was approved in the U.S. in 2023, to boost its cardiac rhythm management business sales by around 6% to 7%.


### Dive Insight:


The Aveir system contributed to the 7.5% organic sales growth in Abbott's rhythm management unit in the first quarter. CEO Robert Ford mentioned during an April earnings call that Aveir “rapidly captured market share” in the single-chamber pacing segment after its U.S. approval last year. Ford highlighted the device’s longer-lasting battery and the ability to upgrade from a single-chamber device to a dual-chamber setup.


Abbott currently holds about a 50% market share in the U.S. for single-chamber pacing, according to Ford. The company is now aiming to increase sales of the dual-chamber device. Ford noted a significant ramp-up in the first quarter and believes further growth is likely as more physicians are trained to use Aveir DR.


Ford emphasized the uniqueness of the procedure, stating, “This is probably the first time in 30 years there’s a significant change in how these devices are implanted.” Abbott's strategy focuses on achieving excellent clinical results, thoughtfully opening new centers, and providing thorough training.


With the CE mark, Abbott can now expand Aveir DR commercialization to the European Union and other markets that recognize CE marks. The single-chamber Aveir device also received a CE mark in 2023. This progress has helped Abbott recover from issues with its older Nanostim device, which was halted due to a part detachment, and positioned the company as a competitor to Medtronic in the leadless pacemaker market.