Medtronic secures European CE mark for five conduction system pacing devices

USA—Medtronic has received European CE marking for five pacemakers in its Vitalis portfolio, expanding treatment options for patients who require conventional pacing or more specialised approaches to managing heart rhythm disorders.

The devices, ReSyncra CSP, Restoria CSP, Refina CSP, Effectra and Confirma, include features designed to support conduction system pacing (CSP), which targets the heart’s natural electrical pathways to improve heartbeat coordination.

New devices target specialised pacing needs

Unlike conventional pacemakers, which typically stimulate the right ventricle, CSP aims to activate the heart’s electrical conduction system more directly.

This approach may help coordinate ventricular contractions and provide an alternative for selected patients who require pacing support.

The portfolio includes ReSyncra CSP, which offers an option for patients who need cardiac resynchronisation therapy (CRT) but cannot achieve effective results with conventional biventricular pacing.

Traditional CRT uses electrical stimulation to coordinate the contractions of the heart’s right and left ventricles.

ReSyncra CSP instead uses conduction system pacing to improve ventricular synchronisation.

It also incorporates Medtronic’s AdaptivCSP technology, which automatically adjusts pacing timing to help optimise coordination in patients with heart failure who cannot achieve effective CRT through conventional approaches.

Three devices in the portfolio, ReSyncra CSP, Restoria CSP and Refina CSP, also feature the CSP Morphology Monitor.

This function allows clinicians to monitor aspects of CSP therapy remotely, supporting follow-up and assessment throughout treatment.

Robert Kowal, general manager of cardiac pacing therapies within Medtronic’s electrophysiology therapies operating unit, said the portfolio aims to personalise treatment, simplify clinical workflows and support patients with different pacing needs.

CSP adoption and clinical considerations

Conduction system pacing has attracted growing clinical interest as physicians explore alternatives to conventional pacing and approaches to improving cardiac synchronisation.

However, its suitability depends on individual patient characteristics, and some studies have reported higher peri-procedural complication rates than conventional pacing.

The new portfolio gives Medtronic additional options across the cardiac pacing market, where device manufacturers compete on clinical performance, monitoring capabilities and technologies designed to address specific patient needs.

Wider adoption of CSP will depend partly on clinical evidence, physician training and the ability to demonstrate benefits for appropriate patient groups.

Medtronic maintains a strong US market position

GlobalData market modelling indicates that Medtronic held 58.7% of the US pacemaker market in 2025, followed by Abbott with 35% and Biotronik with 3%.

The global pacemaker market is projected to grow at a compound annual growth rate of 4.9%, reaching US$6.2 billion by 2035, according to GlobalData analysis.

Expanding specialised pacing options and incorporating monitoring technologies could provide manufacturers with opportunities to differentiate their devices as demand for cardiac rhythm management continues to grow.

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