Biotronik Tackles Emerging Technique in IDE Trial

Biotronik has enrolled the first patient in an IDE to examine the use of its Solia S pacing lead when implanted in the left bundle branch (LBB) area.

The Lake Oswego, OR-based company said its trial is expected to enroll up to 260 patients for evaluation at up to 25 sites in the United States. Biotronik said the trial would be conducted over 12 months and would include the evaluation of safety and effectiveness as well as patient quality-of-life measurements.

LBB area pacing, a form of conduction system pacing, is an emerging technique for providing a more physiologic activation of cardiac tissue in patients needing ventricular pacing support. This pacing site may also help avoid the detrimental effects of traditional right ventricular pacing.

Compared to traditional right ventricular pacing, conduction system pacing such as LBB area pacing has been proposed as a more physiologic alternative.

“There is a great deal of excitement surrounding conduction system pacing, and we are eager to provide additional clinical data to physicians who want to use our leads for this emerging pacing option,” said David Hayes, CMO of Biotronik. “Biotronik is committed to advancing cardiac care, and we will continue to support efforts that enable physicians to treat their patients most effectively.”

The enrollment follows closely behind a partnership Biotronik announced with AliveCor. The collaboration is designed to use artificial intelligence to improve the delivery of connected care in cardiac diagnostics and remote patient monitoring.