FDA approves new catheter system for left bundle branch area pacing

Fact checked byErik Swain

Key takeaways:

The FDA approved a stylet-driven lead and delivery catheter system for left bundle branch area pacing
Approval was based on the results of the BIO-CONDUCT trial presented at Heart Rhythm 2024.

Biotronik announced it received FDA labeling approval of its stylet-driven lead and delivery catheter system for left bundle branch area pacing.

Approval of the system (Selectra 3D catheter and Solia S lead) was based on the results of the BIO-CONDUCT study presented at the Heart Rhythm 2024 and published in HeartRhythm. The system demonstrated high implant success (95.7%, beating a performance goal of 88%) and a low level of lead-related complications (1.7%, all of which were lead dislodgements) at 3 months, according to a press release issued by the company.

Larry Chinitz

“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,” Larry Chinitz, MD, cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center, said in the release. “The Solia lead in particular offers several advantages over legacy LBBAP leads, including the ability to continuously pace off the stylet during implantation.”

Reference:

Liu CF, et al. Heart Rhythm. 2024;doi:10.1016/j.hrthm.2024.05.007.

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Sources/Disclosures

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Source:

Press Release

Disclosures: Chinitz reports he is on the speaker’s bureau for Abbott, Biosense Webster, Biotronik and Medtronic.

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FDA approves new catheter system for left bundle branch area pacing

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