Stereotaxis and CardioFocus Join Forces to Develop Robotic Pulsed Field Ablation System

Stereotaxis, a leader in robotic technologies for cardiac procedures, has announced a strategic partnership with CardioFocus to develop an innovative robotic pulsed field ablation (PFA) system for the treatment of cardiac arrhythmias. This collaboration marks a significant step forward in combining advanced ablation techniques with robotic precision in cardiac care.

Integration of Cutting-Edge Technologies

The new system will integrate CardioFocus' CE-marked Centauri PFA system, which has already been used to treat over 9,000 patients, with Stereotaxis' Magic robotic cardiac ablation catheter. This fusion of technologies aims to leverage the strengths of both companies, potentially offering improved outcomes for patients suffering from complex arrhythmias.

Stereotaxis CEO David Fischel emphasized the synergy between robotics and PFA, stating, "The precision, stability, and safety profile of robotics are a good fit for pulsed field ablation." This sentiment underscores the potential benefits of combining these two advanced medical technologies.

Clinical Progress and Regulatory Pathway

The collaboration between Stereotaxis and CardioFocus has already yielded promising results, with the completion of bench and preclinical testing. This progress positions the partners to initiate clinical trials in the near future, a crucial step towards regulatory authorization and commercialization.

Fischel outlined the next steps, saying, "We are now focused on transitioning to first human use and advancing the regulatory process in the coming few months." This timeline aligns with Stereotaxis' earlier predictions of human testing beginning in 2025, with potential European market entry within 12 months thereafter.

Market Dynamics and Strategic Positioning

While Stereotaxis has primarily focused on complex arrhythmias, a market segment somewhat insulated from the recent shifts caused by PFA devices, the company recognizes the changing landscape. Fischel acknowledged that market dynamics "are distracting for our customers," highlighting the strategic importance of developing a PFA system to meet long-term client needs.

This move into PFA technology complements Stereotaxis' recent achievements, including the July 2025 510(k) clearance for its robotically navigated electrophysiology mapping catheter. As the cardiac ablation market continues to evolve, the partnership with CardioFocus positions Stereotaxis to remain at the forefront of innovative cardiac care solutions.