Medical Device Network

Abbott gains CE approval for dual-chamber leadless pacemaker

The pacemaker market is growing due to the increased population at risk of cardiovascular diseases and continuing advancements in tech.

Abbott’s dual-chamber leadless pacemaker product, the Alveir DR, has gained Conformité Européenne (CE) approval to be marketed in the European Union. This provides an opportunity for Abbott to compete with Medtronic, which currently has a monopoly on the market with its Micra AV product line. The dual-chamber leadless pacemaker market was worth $185.9 million globally in 2023 and is projected to reach sales of $438 million in 2033 at a compound annual growth rate (CAGR) of 8.95%, according to GlobalData, a leading data and analytics company.

The overall pacemaker market has shown stable growth in recent years, and this is expected to continue for the foreseeable future. The growth is due to the growing population at risk of cardiovascular diseases and continuing advancements in technology that improve upon the current limitations of pacemaker systems. In turn, this will also promote growth in the dual chamber leadless market, as the drivers of the market remain relatively the same. One barrier to this growth is the cost of dual-chamber leadless pacemakers. However, future technological advancements in this space will likely drive down the price, thus increasing the accessibility of these products.

The benefits of leadless pacemakers compared to traditional pacemakers include the lack of a transvenous lead, which eliminates the potential for complications with that lead. Additionally, the implantation of the leadless pacemaker is significantly easier and there is no longer a need for a subcutaneous pocket to implant the device, therefore removing the threat of pocket-related infections.

While the dual-chamber leadless pacemaker market is relatively new, the potential for growth in this sub-market is promising due to the transition being seen in the healthcare system from traditional pacemakers to leadless pacemakers that provide fewer complications. The CE approval is a good sign for Abbott, and the expansion of leadless pacemakers provides an opportunity to obtain a portion of the market share in the future. Although Medtronic is still expected to dominate this sub-market, the company may not hold the same monopoly on leadless pacemakers in the future as it does currently.