FDA Approves Biotronik's Selectra 3D Catheter and Solia S Lead for Left Bundle Branch Area Pacing

Key Insights

• The FDA has granted approval for Biotronik's Selectra 3D catheter, used with the Solia S lead, for left bundle branch area pacing (LBBAP).
• This marks the first FDA-approved stylet-driven lead and dedicated delivery catheter system for LBBAP, offering a new option for cardiac pacing.
• The BIO-CONDUCT trial demonstrated a 95.7% implant success rate and a low 1.7% lead-related complication rate at 3 months with the Solia S lead in LBBAP.

Biotronik has received FDA approval for its Selectra 3D catheter in conjunction with its Solia S lead for use in left bundle branch area pacing (LBBAP). This approval marks a significant advancement in cardiac pacing technology, providing physicians with the first and only FDA-approved stylet-driven lead and dedicated delivery catheter system specifically designed for LBBAP.

The Solia S lead and Selectra 3D catheter have already seen widespread use, with over 80,000 patients treated globally. The new FDA indication expands their application to the evolving technique of pacing the heart's natural conduction system by targeting the left bundle branch area.

BIO-CONDUCT Trial Results

Data from the BIO-CONDUCT study, presented at HRS 2024, underscore the reliability and efficacy of the Solia S lead and Selectra 3D catheter system. The trial demonstrated a high implant success rate of 95.7% and a low lead-related complication rate of 1.7% at 3 months post-implantation. These results suggest a favorable safety and performance profile for the system in LBBAP procedures.

According to Dr. Larry Chinitz, Director of NYU Langone’s Heart Rhythm Center and lead investigator of the BIO-CONDUCT trial, "Results from the BIO-CONDUCT trial show the Solia S lead and Selectra 3D catheter 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 Solia S Lead

The Solia S lead offers key advantages over previous-generation LBBAP leads. Its design allows for continuous pacing off the stylet during implantation, potentially improving procedural efficiency and patient outcomes. This feature, combined with the precision delivery of the Selectra 3D catheter, provides electrophysiologists with enhanced control and accuracy during LBBAP procedures.

Industry Impact

"We are committed to physicians with innovative products and solutions, and the Solia S lead with Selectra 3D catheter for LBBAP is a perfect example of physician-driven advancement of care," said Ryan Walters, BIOTRONIK US President. "It is important we meet and support that evolution."