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Abbott obtains CE mark for dual-chamber leadless pacemaker

Abbott has received a CE mark for its dual-chamber leadless pacemaker, enabling sales in Europe. The Aveir DR system, with synchronized pacemakers for the right atrium and right ventricle, stands out from single-chamber devices like Medtronic’s Micra.

Approved in the U.S. in 2023, the device is crucial for Abbott’s cardiac rhythm management business, aiming for 6% to 7% sales growth. Aveir contributed to a 7.5% organic sales growth in the first quarter. Holding around 50% of the U.S. single-chamber pacing market, Abbott is now focused on boosting dual-chamber device sales. The company saw significant growth in the first quarter and expects more as physician training increases.

With the CE mark, Abbott can commercialize Aveir DR in the EU and other markets accepting CE marks. This milestone helps Abbott recover from past issues with its Nanostim device and positions it as a rival to Medtronic in the leadless pacemaker market.