What's Happening?
Stereotaxis has announced a partnership with CardioFocus to develop a robotic pulsed field ablation (PFA) system aimed at treating cardiac arrhythmias. The collaboration will integrate CardioFocus' Centauri
PFA system, which has been used in over 9,000 patient treatments, with Stereotaxis' Magic robotic cardiac ablation catheter. The companies have completed bench and preclinical testing and are preparing to start clinical trials to support authorization and commercialization. Stereotaxis CEO David Fischel emphasized the precision, stability, and safety of robotics as a fitting match for PFA technology, which is designed to enable complex procedures that are challenging to perform without robotics.
Why It's Important?
The development of a robotic PFA system represents a significant advancement in the treatment of cardiac arrhythmias, potentially improving patient outcomes through enhanced precision and safety. This partnership positions Stereotaxis to meet long-term goals and address market dynamics that are shifting with the introduction of PFA devices. The integration of robotics into PFA systems could lead to more effective treatments and expand the capabilities of cardiac arrhythmia management, benefiting healthcare providers and patients alike.
What's Next?
Stereotaxis and CardioFocus are transitioning to first human use and advancing the regulatory process in the coming months. The clinical trials will be crucial for obtaining authorization and commercialization of the robotic PFA system. Stereotaxis has already received 510(k) clearance for its robotically navigated electrophysiology mapping catheter, indicating progress in regulatory approvals. The company anticipates that at least one solution will enter human testing in 2025 and reach the European market within 12 months.
