Medtech companies working together on robotic PFA system
Stereotaxis and CardioFocus, two U.S. medtech companies, are working together to push a robotic pulsed field ablation (PFA) system toward commercialization.
St. Louis-based Stereotaxis is already a known leader in the electrophysiology (EP) robotics space. Marlborough, Massachusetts-based CardioFocus, meanwhile, is known for developing and manufacturing advanced treatments for cardiac arrhythmias. The collaboration involves pairing the MAGiC robotic cardiac ablation catheter from Stereotaxis with the Centauri PFA system from CardioFocus. The companies hope to provide clinicians with the first-ever robotic PFA technology for treating atrial fibrillation (AFib) and other arrhythmias.
Stereotaxis and CardioFocus have already completed some initial research on the new-look device, including preclinical studies that confirmed the safety was safe for patients. The next steps will include launching a clinical trial and—if the device is successful—earning the necessary regulatory approvals.
“We are excited to collaborate with CardioFocus to accelerate bringing robotic PFA to the Electrophysiology community,” David Fischel, Stereotaxis chairman and CEO, said in a statement. “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,” said Stephan Ogilvie, CEO of CardioFocus. “Through rigorous scientific development, we have customized our proven PFA waveform for Stereotaxis’ RMN systems and anticipate the collaboration will advance patient care in electrophysiology.
PFA continues to gain momentum
The rise of PFA is one of the biggest stories in all of electrophysiology. PFA uses high-voltage electrical pulses create holes in cell walls that cause cell death. It is used as a more controllable way to treat paroxysmal and persistent AFib, as opposed to the heat and cold used by radiofrequency ablation and cryoablation. It is consistently linked to positive patient outcomes and a superior safety profile, and cardiologists are increasingly turning to PFA as a go-to treatment option.
A handful of PFA technologies have already gained U.S. Food and Drug Administration approval, and many more are expected to follow, but none of them have been powered by robotic assistance. Stereotaxis and CardioFocus hope to change all of that through their partnership.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.