Medtronic (NYSE: MDT) has claimed a CE Mark for its latest portfolio of pacemakers designed for conduction system pacing, which taps into the heart’s natural electrical pathways.
The European approval for the Vitalis implant family includes the ReSyncra CSP, Restoria CSP, Refina CSP, Effectra and Confirma pacemakers designed to address a wide variety of patients.
ReSyncra CSP, for example, carries additional technology aimed at people who may benefit from cardiac resynchronization therapy, or CRT, but have not seen success with traditional approaches that aim to restore the proper timing of beats between the heart’s left and right ventricles.
The device aims to improve synchronization by targeting the bundles of specialized, conductive tissues that direct the beating cardiac muscles, instead of sending signals to the ventricles themselves.
“Our new pacemakers build on Medtronic’s long history of leadership in cardiac electrophysiology therapies,” Dr. Robert Kowal, Medtronic’s general manager of cardiac pacing therapies, said in a statement. “From patients requiring traditional pacing support to those who may benefit from conduction system pacing or cardiac resynchronization therapy, this portfolio was designed to personalize therapy, simplify physician workflows, and support patients throughout their healthcare journey.”
Related: Medtronic initiates global cardiac pacing study in new patient population
This past March, Medtronic obtained an expanded FDA approval of its OmniaSecure lead, adding conduction system pacing support with placements in the heart’s left bundle branch for its implantable defibrillators.
In Europe, the company also holds conduction system pacing CE Marks for the SelectSecure MRI SureScan Model 3830 pacing lead, the C320LBB lead placement system, and a rotatable connector accessory for continuous signal monitoring during implantation.
