#United States #San Francisco #FDA Clearance #medical technology #SoloPace FUSION

SoloPace FUSION: A Leap in Temporary Pacing Technology

On March 31, 2026, Solo Pace Incorporated announced the US commercial launch of its revolutionary SoloPace FUSION™ Temporary Pacing System following FDA 510(k) clearance. This innovative device is poised to improve procedural safety and efficiency during transcatheter heart valve (THV) interventions, particularly transcatheter aortic valve replacement (TAVR).

Streamlined Design Features

The SoloPace FUSION system is a single-use, sterile kit crafted to simplify the temporary pacing process. It integrates essential functions—guide wire operation, left-ventricular pacing, and patient grounding—into one easy-to-use instrument. This design aims to standardize and optimize pacing procedures, minimizing the risk of complications and enhancing overall workflow in catheterization labs.

A key factor in the development of this system was the increasing global demand for efficient technologies that complement the rising volume of TAVR procedures. As these procedures become more common, the need for reliable pacing solutions has never been more critical.

Benefits for Cardiology Practitioners

For interventional cardiologists accustomed to conventional right-ventricular (RV) pacing leads, the SoloPace FUSION offers significant advantages. By eliminating the need for RV lead placements, the system not only reduces the required venous access but also lowers the associated risks such as perforations and other complications. Additionally, it addresses challenges faced with improvised left-ventricular (LV) pacing techniques, which often result in inconsistent capture and workflow variability.

Dr. Stanley J. Chetcudi, MD, Director of the Cardiac Catheterization Laboratory at Michigan Health, shared insights into the early use of the SoloPace FUSION. He noted, “In our initial experience, we've successfully transitioned from conventional RV pacing during many TAVR procedures. This system introduces reliable LV pacing, allowing us to track smoothly and maintain stability during valve deployment.”

Enhanced Workflow and Safety

The SoloPace FUSION is designed to operate in conjunction with the existing SoloPace CONTROL external pulse generator (EPG). This generator is tailored to boost workflow efficiency and mitigate the risk of communication errors that can lead to pacing complications. The system incorporates operator-specific protocols, automated checks for pace capture, remote sterile control operation, and clear visual indicators, all contributing to a safer and more manageable procedure environment.

“Achieving clearance for our SoloPace FUSION System signifies a monumental milestone in our journey,” stated David Daniels, MD, CEO of Solo Pace. “This innovative temporary pacing solution addresses the critical requirements of the ever-growing TAVR procedure market in the US, enhancing procedural safety and efficiency while eliminating the reliance on makeshift solutions.”

About Solo Pace, Inc.

Based in San Francisco, California, Solo Pace, Inc. is dedicated to pioneering solutions within the realm of transcatheter heart valve pacing. As the exclusive distributor in the US, Merit Medical is set to play a key role in the roll-out of the SoloPace FUSION System. For more information about the company and its products, please visit www.solopace.health.

Conclusion

The introduction of the SoloPace FUSION Temporary Pacing System represents a significant advancement in medical technology aimed at enhancing patient care in cardiac procedures. With its practical design and operational efficiency, SoloPace is set to revolutionize the way TAVR and other THV procedures are conducted in the US medical landscape.