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LAKE OSWEGO, Oregon, USA

BIOTRONIK Receives FDA Approval for Solia CSP S, World’s First Pacing Lead Specifically Designed For LBBAP Heart Rhythm 2026: Hands-On Demonstrations Available

BIOTRONIK, a global leader in cardiovascular medical technology, today announced its Solia CSP S pacing lead has received approval from the U.S. Food and Drug Administration (FDA). With this approval, Solia CSP S is now commercially available in the United States, expanding access to a dedicated solution for Left Bundle Branch Area Pacing (LBBAP).

Solia CSP S is the world’s first pacing lead to combine the support of a stylet-driven lead platform with the efficiency of a fixed helix – specifically engineered for LBBAP procedures.

"FDA approval for the Solia CSP S pacing lead represents an important step forward in the continued advancement of physiologic pacing," said Larry Chinitz, MD, Director of Cardiac Electrophysiology at NYU Langone's Heart Rhythm Center, Co-Director of NYU Langone Heart and Principal Investigator of the BIO-CONDUCT study. "Investigator experiences from the BIO-CONDUCT IDE trial highlight the value of a product specifically engineered for LBBAP.”

Indicated for LBBAP placement, the lead’s optimized helix, enhanced steerability, and simplified handling are designed to reduce preparation time while improving procedural efficiency and ease of delivery.

"The Solia CSP S pacing lead provides a purpose-built solution long overdue for conduction system pacing," said Christopher Liu, MD, Medical Director of Cardiac Electrophysiology Services for the New York-Presbyterian – Weill Cornell Network. "With the combination of a stylet-driven platform and fixed helix, Solia CSP S is a new generation lead that can now be used to achieve physiologic pacing for our patients.”

Physicians and healthcare professionals will have the opportunity to experience Solia CSP S firsthand at the Heart Rhythm Society Annual Scientific Sessions in Chicago, April 23–26, 2026. Attendees are invited to visit the BIOTRONIK booth for live demonstrations, hands-on training, and expert-led discussions on LBBAP and physiologic pacing.

“With FDA approval, we reinforce our dedication to continued innovation in the critical field of CSP,” said Ryan Walters, President, BIOTRONIK. “Solia CSP S reflects our commitment to advancing physiologic pacing and equipping clinicians with solutions that enhance patient outcomes.”

For more information about Solia CSP S and BIOTRONIK’s LBBAP portfolio, please visit www.biotronik.com.

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About BIOTRONIK

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.