Biotronik's Selectra 3D Catheter and Solia S Lead Gain FDA Approval for Left Bundle Branch Area Pacing
Key Insights
Biotronik received FDA approval for its Selectra 3D catheter (search) and Solia S lead (search), making them the first stylet-driven system approved for Left Bundle Branch Area Pacing (LBBAP).
The approval is based on data from the BIO-CONDUCT trial, which demonstrated a 95.7% implant success rate and a 1.7% lead-related complication rate at three months.
The Solia S lead (search) offers advantages over legacy leads, including the ability to continuously pace off the stylet during implantation, according to Dr. Larry Chinitz.
Biotronik has secured FDA approval for its Selectra 3D catheter (search) and Solia S lead (search) for use in left bundle branch area pacing (LBBAP). This approval marks the system as the first and only stylet-driven lead and dedicated delivery catheter system sanctioned by the FDA for LBBAP, according to the company.
The Solia S and Selectra 3D have already seen use in over 80,000 patients globally. The expanded indication bolsters their application in pacing the heart’s natural conduction system, specifically targeting the left bundle branch area.
Clinical Trial Data
Data from Biotronik’s BIO-CONDUCT trial showed promising results. Dr. Larry Chinitz, a cardiac electrophysiologist at NYU Langone’s Heart Rhythm Center and the lead investigator of the trial, reported "excellent outcomes" and highlighted the system's reliability. He also noted that the Solia lead provides "several advantages" over older leads, including continuous pacing off the stylet during implantation.
At the Heart Rhythm Society (HRS) 2024, data was presented showing a 95.7% implant success rate and a 1.7% lead-related complication rate at three months post-implantation.
Company Statement
Ryan Walters, President of Biotronik U.S., stated, "We are committed to physicians with innovative products and solutions, and the Solia S lead (search) with Selectra 3D catheter (search) for LBBAP is a perfect example of physician-driven advancement of care. It is important we meet and support that evolution."