First Implant of Next-Generation Lead for Conduction System Pacing in BIO-Master.CSP Clinical Trial
BIOTRONIK, a global leader in cardiovascular, endovascular, and neuromodulation solutions, is pleased to announce the first in-human implantations in BIO|Master.CSP study examining the use of the investigational BIOTRONIK 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 strong experience of Solia S in 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 system has been implanted in Auckland, New Zealand at the Auckland City Hospital by Dr. Matthew O’Connor, Cardiac Electrophysiologist at the Auckland City Hospital.
“It was great to see how smoothly the case went. The lead performed perfectly and I'm looking forward to future implants. I appreciate a lot of work and many months and years of work go into these things. For me as an implanting physician, it is very satisfying to see a finished product that works this nicely,” says Dr. O’Connor.
BIO|Master.CSP trial seeks to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S investigational pacing lead used in the left bundle branch area. Successful lead implant, user satisfaction as well as long-term performance will be assessed.
“There’s little doubt that left bundle branch area pacing is an opportunity for improved care for many patients compared to traditional apical pacing,” says Dr. David Hayes, Chief Medical Officer of BIOTRONIK. “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.”
-END-
References:
- 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.
- 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.
About BIOTRONIK
At BIOTRONIK, patient well-being is our top priority and has been for over 60 years. BIOTRONIK is a leading global medical technology company with products and offerings 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 therapies. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries across the Americas, EMEA (Europe, the Middle East, and Africa), and Asia-Pacific.
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