Medtronic’s Vitalis portfolio of next-generation pacemakers, each of which has been engineered for conduction system pacing (CSP) therapy, has received a European CE mark.
In contrast to conventional pacemakers that non-selectively stimulate the heart from the right ventricular wall, CSP directly targets the heart’s natural electrical pathways to simultaneously regulate heart rate and heartbeat coordination, delivering a “more physiologic” pacing option for patients, Medtronic stated.
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The five newly approved pacemakers – ReSyncra CSP, Restoria CSP, Refina CSP, Effectra, and Confirma – include advanced features purpose-built for CSP therapy.
Medtronic’s ReSyncra CSP pacemaker introduces a new treatment option for patients who may benefit from cardiac resynchronisation therapy (CRT) and are indicated for a conventional biventricular pacemaker, but for whom effective CRT cannot be achieved.
Traditional CRT attempts to restore coordination between the right and left sides of the heart by pacing both ventricles. Instead of relying solely on traditional biventricular pacing, ReSyncra CSP uses CSP to improve ventricular synchronisation. The pacemaker, which Medtronic says is the most advanced model within its newly cleared portfolio, also includes AdaptivCSP. This feature automatically adjusts pacing timing to help optimise heart synchrony for patients with heart failure in whom effective CRT cannot be achieved.
Meanwhile, additional features included in certain of the portfolio pacemakers include advanced remote monitoring capabilities with ReSyncra CSP, Restoria CSP, and Refina CSP pacemakers through the CSP Morphology Monitor feature that provides clinicians with the ability to monitor CSP therapy over the course of a patient’s treatment.
Robert Kowal, general manager for cardiac pacing therapies within Medtronic’s electrophysiology therapies operating unit, commented: “From patients requiring traditional pacing support to those who may benefit from conduction system pacing or cardiac resynchronisation therapy, this portfolio was designed to personalise therapy, simplify physician workflows, and support patients throughout their healthcare journey.”
CSP has gained traction in recent years given its perceived appropriateness for certain cardiac patients versus conventional pacemakers. However, some research indicates that CSP has been associated with higher peri-procedural complication rates versus conventional pacing.
A GlobalData market model reveals that Medtronic held a lead position in the US pacemaker market with a 58.7% share in 2025, followed by Abbott with a 35% share in second place, and Biotronik at a distant third with a 3% share. Meanwhile, the global pacemaker market is growing at a compound annual growth rate (CAGR) of 4.9%, as per GlobalData analysis, and is projected to reach a $6.2bn valuation in 2035.
