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

In a significant move that combines robotic precision with cutting-edge cardiac treatment technology, Stereotaxis and CardioFocus have announced a partnership to develop a robotic pulsed field ablation (PFA) system for treating cardiac arrhythmias. This collaboration marks a notable advancement in the field of electrophysiology, promising to enhance the safety and efficacy of arrhythmia treatments.

Strategic Partnership Leverages Complementary Technologies

The newly announced partnership will integrate CardioFocus' CE-marked Centauri PFA system with Stereotaxis' Magic robotic cardiac ablation catheter. The Centauri system, which has already been used to treat over 9,000 patients, brings proven PFA technology to the table. Meanwhile, Stereotaxis contributes its expertise in robotic navigation, known for its precision and stability in complex cardiac procedures.

David Fischel, CEO of Stereotaxis, 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 for the combined technologies to address the challenges faced in treating complex arrhythmias.

Advanced Development and Regulatory Progress

The collaboration between Stereotaxis and CardioFocus has already yielded promising results. The partners have completed bench and preclinical testing of the integrated system, paving the way for the next crucial phase of development. According to Fischel, the immediate next steps involve "transitioning to first human use and advancing the regulatory process in the coming few months."

This progress aligns with Stereotaxis' broader strategy in the PFA space. In March, Fischel had disclosed that the company was engaged in "extensive preclinical testing" with three partners, each offering "an independent shot to bring a good solution to market." The CEO had predicted that at least one solution would enter human testing in 2025 and potentially reach the European market within 12 months.

The regulatory landscape for the partners appears favorable, with Stereotaxis recently receiving 510(k) clearance from the FDA for its robotically navigated electrophysiology mapping catheter in July. This clearance could potentially expedite the path to market for the new robotic PFA system.