BIOTRONIK Receives FDA Approval for LBBAP Indication on Pacing Lead and Delivery Catheter System

BIOTRONIK Press Release

LAKE OSWEGO, Oregon, USA – BIOTRONIK, a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) labeling approval of its Selectra 3D catheter in conjunction with its Solia S lead for use in left bundle branch area pacing (LBBAP). The two products represent the first and only FDA-approved stylet-driven lead and dedicated delivery catheter system approved for LBBAP.

The Solia S lead and Selectra 3D catheter have been used in more than 80,000 patients worldwide.1 The additional indication supports their use in the evolving technique of pacing the heart’s natural conduction system, specifically targeting the left bundle branch area. 

“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,” said Larry Chinitz, M.D., cardiac electrophysiologist, Director of NYU Langone’s Heart Rhythm Center in New York City, and lead investigator of the BIO-CONDUCT trial. “The Solia lead in particular offers several advantages over legacy LBBAP leads, including the ability to continuously pace off the stylet during implantation.”

Data from the BIO-CONDUCT study was presented at HRS 2024 as a late-breaking clinical trial, demonstrating a high level of implant success (95.7%) and a low level of lead-related complications (1.7%) of Solia S leads in LBBAP at 3 months.2

“LBBAP is a therapy on the rise,” said David Hayes, M.D., Chief Medical Officer, BIOTRONIK Inc. “We are proud to support continuing research into this growing practice and provide the tools for cardiac patients to receive the best possible care.”

“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.”

About BIOTRONIK: 

At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries. 
 
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References

1. Data on file. 

2. Chinitz L, et al. Left Bundle Branch Area Pacing using a Stylet Driven, Retractable Helix Lead: Results from a Prospective, Multicenter Trial (The BIO-CONDUCT Study). Presented at Heart Rhythm Society; May 19, 2024; Boston, MA.