Stereotaxis and CardioFocus have announced that they have entered into a collaboration agreement to advance robotic pulsed field ablation (PFA) technology towards commercialisation.
This collaboration is set to combine the proprietary technologies of both companies to accelerate commercial availability of the “first ever” robotic PFA solution for the treatment of cardiac arrhythmias, according to a press release.
CardioFocus’ Centauri PFA system is CE-marked and has been used to treat more than 9,000 patients across Europe, with clinical experience reported in over 40 publications demonstrating high levels of procedural efficiency, durable cardiac lesions, and low rates of complications.
Stereotaxis’ robotic magnetic navigation (RMN) systems introduce the precision and safety of advanced robotic technology in cardiac ablation procedures, with clinical value demonstrated in more than 150,000 cardiac ablation patients treated globally and over 500 publications, the company claims.
CardioFocus and Stereotaxis are collaboratively working to pair the Centauri PFA system with Stereotaxis’ Magic robotic cardiac ablation catheter. The two companies have successfully completed extensive bench and preclinical testing of Centauri with Magic, with recent pivotal preclinical studies demonstrating safe, efficient and “impressive” lesion delivery, including deep durable lesions in ventricular tissue.
The collaboration agreement entered into by the companies supports the advancement of this joint solution to a clinical trial, facilitating regulatory compatibility and commercial availability of Magic and Centauri, the press release adds.
“We are excited to collaborate with CardioFocus to accelerate bringing robotic PFA to the electrophysiology community,” said David Fischel, Stereotaxis’ chairman and chief executive officer (CEO). “The precision, stability and safety profile of robotics with the efficiency and attractive lesions created by Centauri is a winning combination. We look forward to transitioning to first human use and advancing the regulatory process in the coming few months.”
“The combination of our patented PFA waveform and the Magic catheter has the potential to improve patient lives,” added Stephan Ogilvie, CEO of CardioFocus. “Through rigorous scientific development, we have customised our proven PFA waveform for Stereotaxis’ RMN systems and anticipate the collaboration will advance patient care in electrophysiology.”
