Medtronic secures CE Mark for new cardiac pacing portfolio

pharmafile | October 30, 2026 | News story | |  Cardiology, Devices, Oncology, cardiology, medical devices 

Medtronic has received CE Mark approval for its Vitalis portfolio of five pacemakers, including a device designed for patients who may benefit from cardiac resynchronisation therapy (CRT) but in whom effective treatment using conventional biventricular pacing cannot be achieved.

The portfolio comprises ReSyncra CSP, Restoria CSP, Refina CSP, Effectra and Confirma pacemakers, offering a range of pacing options, including those designed for conduction system pacing (CSP).

CSP uses the heart’s natural electrical conduction pathways to regulate heart rate and improve coordination between the ventricles. Medtronic said its ReSyncra CSP pacemaker combines this approach with features intended to help optimise synchronisation for patients with heart failure who cannot achieve effective CRT through conventional methods.

The portfolio also includes pacing algorithms to personalise treatment, monitoring capabilities to assess CSP therapy, and features designed to accommodate radiotherapy and magnetic resonance imaging (MRI). Medtronic said its Day Zero MRI feature allows patients to undergo MRI scans immediately after implantation, without the usual four-to-six-week wait.

Other features include RadiaSure technology, which the company says helps devices tolerate radiation doses associated with nearly all cancer treatments, and Allometric Pacing, which enables clinicians to tailor pacing rates according to patient characteristics including height and ejection fraction.

The launch is accompanied by Medtronic’s CSP procedural tools, including the SelectSecure MRI SureScan Model 3830 pacing lead and the C320LBB delivery system for targeted lead placement.

Robert C. Kowal, General Manager of Cardiac Pacing Therapies at Medtronic, said the portfolio was designed to offer options ranging from conventional pacing support to CSP and CRT, while allowing clinicians to personalise therapy.

Pic: Stephen Andrews