Merit Medical Systems Announces U.S. Commercial Release of the SOLO PACE FUSION™ Temporary Pacing System Following FDA 510(k) Clearance
SOUTH JORDAN, Utah – January 09, 2026 – Merit Medical Systems, Inc. (NASDAQ: MMSI), a global manufacturer and marketer of healthcare technology, today announced the U.S. commercial release of the SOLO PACE FUSION™ Temporary Pacing System, engineered and manufactured by Solo Pace, Inc. and exclusively distributed by Merit Medical in the United States. The launch follows SOLO PACE Inc.’s recent receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for the system.
The SOLO PACE FUSION single use, sterile kit is a purpose-built, streamlined approach to temporary intracardiac pacing for transcatheter aortic valve replacement (TAVR) and other transcatheter heart valve (THV) procedures. By combining guidewire functionality, LV pacing, and patient grounding in one device, SOLO PACE FUSION delivers a standardized, predictable pacing method intended to simplify setup, reduce variability, and improve patient safety.
For programs using conventional right ventricular (RV) pacing leads, FUSION can eliminate the need for RV lead placement and the additional venous access it requires, potentially reducing procedure time, component cost, and complication risk. For programs using improvised LV pacing, FUSION replaces ad-hoc clip assemblies, subcutaneous needles, and exposed-wire connections—which are known sources of inconsistent pace capture and workflow variability—with a fully integrated sterile kit engineered for reliable electrical performance.
SOLO PACE FUSION is designed to be used with the SOLO PACE CONTROL® external pulse generator (EPG), also distributed by Merit Medical. CONTROL provides intuitive, customizable presets tailored for THV pacing workflows and wireless remote control from the sterile field, reducing verbal communication burdens and standardizing intraprocedural temporary pacing sequences. When combined with the FUSION guidewire kit, the system delivers a fully integrated temporary pacing platform engineered for consistency, efficiency, and predictability for THV procedures.
About Solo Pace, Inc.
Solo Pace, Inc., based in San Francisco, California, is a privately held company that is dedicated to bringing solutions to transcatheter heart valve pacing. For more information, visit www.solopace.health
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"SOLO PACE FUSION provides the kind of pacing reliability we want for our patients,” said Paul Teirstein, MD, chief of cardiology and director of interventional cardiology for Scripps Clinic and director of the Scripps Prebys Cardiovascular Institute for Scripps Health (La Jolla, CA). “LV pacing combined with the SOLO PACE generator and remote control reduces the complex pacing variables we manage during TAVR. This integrated system results in consistent, more efficient procedures, and most importantly, improved patient safety.”
SOLO PACE FUSION and SOLO PACE CONTROL are available exclusively through Merit Medical Systems in the United States. Full training and clinical support will be provided to ensure seamless implementation for structural heart programs nationwide.
The SOLO PACE temporary pacing platform expands Merit’s growing Cardiac Therapies portfolio focused on electrophysiology, cardiac rhythm management, and structural heart. Additional innovative solutions include the HeartSpan® family of transseptal products, the SafeGuard Focus Cool™ Compression Device, and the recently acquired Evolution® RL Controlled-Rotation Dilator Sheath.
“SOLO PACE CONTROL and FUSION demonstrate Merit’s continued commitment to delivering innovative products that support better patient care,” said Martha G. Aronson, President and CEO of Merit Medical. “This system is designed to improve safety and procedural outcomes, and we’re proud to offer such an effective treatment option.”
Press Releases
Merit Medical Systems Announces U.S. Commercial Release of the SOLO PACE FUSION™ Temporary Pacing System Following FDA 510(k) Clearance
2026 JAN 09
2025 APR 17