The CE mark clears Medtronic to sell conduction system pacing therapy devices in Europe.
ReSyncra is one of three pacemakers in the Vitalis portfolio with CSP capabilities. CSP is an alternative pacing technique designed to regulate heart rate and heartbeat coordination simultaneously. Medtronic described CSP as “a more physiologic pacing option for patients.”
Like ReSyncra, Restoria CSP and Refina CSP are dual-chamber pacemakers that include Medtronic’s CSP MVP pacing algorithm. Medtronic described CSP MVP as a “pacemaker programming feature designed to enhance atrioventricular synchrony through conduction system pacing sold as an integral component of cardiac pacemakers” when it filed to trademark the term last year.
AdaptivCSP is unique to ReSyncra. The feature automatically adjusts pacing timing to help optimize heart synchrony. Medtronic designed the feature for patients with heart failure in whom effective CRT cannot be achieved. While traditional CRT restores coordination by pacing both ventricles, ReSyncra uses CSP to help improve ventricular synchronization.
Medtronic said it became the first company to receive Food and Drug Administration approval for pacing the heart’s natural conduction system in 2022, when the U.S. regulator expanded the label of a cardiac lead. The FDA approved conduction system products from Biotronik and Boston Scientific in 2024. Abbott shared first-in-human data on its Aveir CSP leadless pacemaker last year.
Medtronic’s newly CE-marked products will slot into a cardiac rhythm management unit that achieved mid-teens growth year over year in Medtronic’s most recent financial quarter. Medtronic named its Micra leadless pacing device and SelectSecure 3830 lead as drivers of the growth.
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