Biotronik gains CE mark for Selectra 3D implant tools to include left bundle branch area pacing

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Biotronik has received CE mark approval for the Selectra 3D implant tools to include left bundle branch area pacing (LBBAP) in addition to His-bundle pacing (HBP).

Commonly referred to as conduction system pacing (CSP) these two approaches have emerged as a physiologic pacing alternative to avoid dyssynchronous contraction of the heart which can induce various negative long-term effects for patients.

Approved in 2021 for HBP, Selectra 3D’s safety and effectiveness for CSP has been shown in over 10 studies with more than 1,000 patients. In the multicentre Belgium registry that enrolled 353 patients in eight centres, the use of Selectra 3D for LBBAP showed 95% implant success, low pacing thresholds (0.6+/-0.4V at 0.4ms) that remained stable at 12 months, and a low lead revision rate of 1.4%.

“With this study we were able to show that left bundle branch area pacing using Biotronik tools is a safe and reliable treatment option. It is associated with high implant success, low pacing thresholds and high safety profile,” commented the leading study author Jan De Pooter (University Hospital Ghent, Ghent, Belgium).


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