The FDA’s approval of the new labeling for the pacing combination makes the products the first and only stylet-driven lead and dedicated delivery catheter system approved by the FDA for LBBAP, the company said in a news release.
Solia S and Selectra 3D have been used in more than 80,000 patients worldwide to date, Biotronik says. The additional indication supports their use in the evolving technique of pacing the heart’s natural conduction system. This method specifically targets the left bundle branch area.
Results from the company’s BIO-CONDUCT trial demonstrated “excellent outcomes,” said Dr. Larry Chinitz. Chinitz serves as a cardiac electrophysiologist at NYU Langone’s Heart Rhythm Center and led the trial. He said Biotronik’s catheter and lead combination proved “extremely reliable.” Additionally, Chinitz says the Solia lead offers “several advantages” over legacy leads. Those advantages include the ability to continuously pace off the stylet during implantation.
Data presented at HRS 2024 demonstrated 95.7% implant success and 1.7% lead-related complications at three months.
“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 U.S. president. “It is important we meet and support that evolution.”
