Biotronik earns expanded FDA nod for pacing lead, delivery catheter system - MassDevice
Biotronik receives FDA approval for Selectra 3D catheter and Solia S lead for left bundle branch area pacing (LBBAP), making it the first stylet-driven lead and dedicated delivery catheter system approved for this use. The products have been used in over 80,000 patients globally, with BIO-CONDUCT trial showing 95.7% implant success and 1.7% lead-related complications at three months.
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Biotronik receives FDA approval for Selectra 3D catheter and Solia S lead for left bundle branch area pacing (LBBAP), making it the first stylet-driven lead and dedicated delivery catheter system approved for this use. The products have been used in over 80,000 patients globally, with BIO-CONDUCT trial showing 95.7% implant success and 1.7% lead-related complications at three months.