FDA Approves Biotronik's Left Bundle Branch Area Pacing System
Key Insights
The FDA has granted approval for Biotronik's Selectra 3D catheter (search) and Solia S lead (search) system for left bundle branch area pacing (LBBAP).
The approval was based on the BIO-CONDUCT trial, which demonstrated a 95.7% implant success rate and a low 1.7% lead-related complication rate.
The Solia S lead (search) offers advantages over previous LBBAP leads, including continuous pacing off the stylet during implantation, according to Larry Chinitz, MD.
Biotronik has received FDA approval for its stylet-driven lead and delivery catheter system designed for left bundle branch area pacing (LBBAP). The system comprises the Selectra 3D catheter (search) and the Solia S lead (search).
The approval was supported by data from the BIO-CONDUCT study, which was presented at Heart Rhythm 2024 and published in HeartRhythm. The study showcased a high implant success rate of 95.7%, surpassing the performance goal of 88%. Furthermore, the system demonstrated a low lead-related complication rate of 1.7% at 3 months, with all complications being lead dislodgements.
BIO-CONDUCT Trial Results
The BIO-CONDUCT trial evaluated the safety and efficacy of the Selectra 3D catheter (search) and Solia S lead (search) system. The primary outcome was implant success, defined as the ability to achieve stable LBBAP with acceptable pacing parameters. Secondary outcomes included lead-related complications and improvements in cardiac function.
Larry Chinitz, MD, cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center, stated, “Results from the BIO-CONDUCT trial show the Solia S lead (search) and Selectra 3D catheter (search) are extremely reliable and provide excellent outcomes in the setting of LBBAP. The Solia lead in particular offers several advantages over legacy LBBAP leads, including the ability to continuously pace off the stylet during implantation.”
Advantages of the Solia S Lead
The Solia S lead (search) provides continuous pacing off the stylet during implantation. This feature allows electrophysiologists to assess pacing parameters in real-time and make necessary adjustments to optimize lead placement. This is a significant advantage over previous LBBAP leads, which required intermittent removal of the stylet to assess pacing parameters.