BIOTRONIK Recruiting Patients for BIO-CONDUCT IDE Trial

BIOTRONIK has enrolled the first patient in the second arm of the BIO-CONDUCT study, a U.S. Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trial examining the use of the company’s investigational next-generation Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). 

Left bundle branch area pacing is an emerging technique 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.^1,2 Building on the results from the Solia S study and subsequent FDA approval for LBBA pacing, the Solia CSP S lead variant has been designed with a fixed helix for simpler preparation, a lengthened helix for ease of LBBA access, and an optimized distal end for high durability.

The first U.S. patient implant with the Solia CSP S pacing lead occurred at NYU Langone Health and was performed by investigators Dr. Lior Jankelson, director of the Inherited Arrhythmia Program at NYU Langone’s Heart Rhythm Center; and Dr. Larry Chinitz, director of Cardiac Electrophysiology, NYU Langone’s Heart Rhythm Center and co-director of NYU Langone Heart.

“As we continue to refine the LBBAP technique in the lab, we need equally refined tools that will lead to successful patient outcomes,” said Dr. Chinitz, the trial’s lead investigator. “The Solia CSP S lead builds on the excellent outcomes we saw with Solia S in BIO-CONDUCT and other studies, and will continue to assist physicians in providing more patients with access to this beneficial procedure.”

The IDE trial’s second arm seeks to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S investigational pacing lead when used in the left bundle branch area. The trial is expected to enroll up to 110 patients for evaluation at up to 14 U.S. sites.  Successful lead implant and complication rates, as well as lead performance and quality of life, will be assessed as patients are followed over 12 months.

“There’s little doubt that left bundle branch area pacing is an opportunity for improved care for many patients compared to traditional apical pacing,” BIOTRONIK Chief Medical Officer Dr. David Hayes stated. “I believe the research and innovation behind Solia CSP S is yet another example of BIOTRONIK’s commitment to partnering with our physician customers to develop novel products and solutions to meet their needs.”

BIOTRONIK is a medical device company that has been developing cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of people diagnosed with heart and blood vessel diseases. BIOTRONIK is headquartered in Berlin, Germany, and represented in more than 100 countries.

References
¹ Zhang S, Guo J, Tao A, et al. Clinical outcomes of left bundle branch pacing compared to right ventricular apical pacing in patients with atrioventricular block. ClinCardiol. 2021 Apr;44(4):481-487. doi: 10.1002/clc.23513.
² Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7.