Biotronik Introduces World’s First and Only System CE Approved for Left Bundle Branch Area Pacing (LBBAP)

March 15, 2024 —  Following the recent CE approval of the Solia S lead1 for LBBAP, Biotronik announces the world’s first and only complete CSP system, now fully CE-approved for Left Bundle Branch Area Pacing (LBBAP).2  

The Biotronik CSP system comprises three proven components: Selectra 3D catheters offering exceptional handling3, Solia S leads – the most popular choice of stylet-driven leads for LBBAP4 providing enhanced stability3, and the Amvia pacemaker family, the first and only family approved for LBBAP.2 Notably, this groundbreaking system is the world’s first and only approved MR Conditional CSP system for LBBAP.2

Dr. Francesco Zanon of Santa Maria della Misericordia Hospital in Rovigo, Italy, who earlier this month implanted the world’s first fully approved CSP system in a male patient suffering from sinus node disease (SND) and paroxysmal atrio-ventricular block (AVB), with moderately reduced ejection fraction (EF), said: “I am really satisfied with the usability and performance of Biotronik's CSP system. I am empowered to deliver superior clinical treatments to my patients using a practical and easy-to-use system that is completely dedicated to LBBAP.”

LBBAP, utilizing the heart's natural conduction system efficiency, is recognized as the preferred approach to physiologic pacing.5 BIOTRONIK’s commitment to CSP has enabled the company to develop a dedicated CSP portfolio. Providing comprehensive training and expert technical support, Biotronik is dedicated to fostering confidence among experienced physicians as well as those new to CSP.

“By introducing the world’s first approved and complete CSP system, we are revolutionizing cardiac rhythm care while leading the CSP field. Biotronik is listening to clinicians' needs, ensuring continuous advancement for the benefit of our patients and healthcare providers," stated Dr. Alexander Uhl, CEO at Biotronik.

Biotronik’s CSP Solution will be showcased at the EHRA Congress in Berlin from April 7-9, 2024. Visitors can attend the CSP-dedicated lunch symposium focused on mastering the stylet-driven approach for LBBAP, as well as the Biotronik booth expert talks led by experienced CSP implanters to gain practical insights and best practice tips & tricks for LBBAP.

For more information: www.biotronik.com

Disclaimer: Selectra 3D and Solia S are not currently approved for CSP indications in the United States. Content is not intended for United States healthcare providers. Local regulatory approval may vary by country.

References:

1. The intended purpose of Solia S 53 and Solia S 60 now explicitly covers Left Bundle Branch Area Pacing (LBBAP).
2. BIOTRONIK Amvia technical manual; Medtronic Azure XT DR MRI SureScan™ manual; Boston Scientific Accolade MRI™ technical manual; Abbott Assurity MRI™ user’s manual; MicroPort Alizea™ implant manual.
3. De Pooter J, Bulava A, Gras D, et al. Utility of a guiding catheter for conduction system pacing. An early multicenter experience. Heart Rhythm O2. 2023; 288(24): 3115.
4. Jastrzębski M, Kiełbasa G, Cano O, et al. Left bundle branch area pacing outcomes: the multicentre European MELOS study. Eur Heart J. 2022; 43(40): 4161-4173.
5. Keene D, Anselme F, Burri H, et al. Conduction system pacing, a European survey: insights from clinical practice. Europace. 2023; 25(5): 1-9.