ST. LOUIS and CARLSBAD, Calif.—Today Stereotaxis and Acutus Medical announced that the first patients have been successfully treated utilizing the integrated Stereotaxis Robotic Magnetic Navigation (RMN) and Acutus AcQMap systems. The integrated technologies are cleared for use in Europe, with additional regulatory clearances expected in the coming months.
The therapeutic approach combines high-resolution real-time cardiac imaging and mapping from Acutus’ AcQMap system with the unprecedented precision and stability of the Stereotaxis Robotic Magnetic Navigation system. The integration of these technologies can enable physicians to clearly see a patient’s arrhythmia pattern and then reach those targets to deliver therapy with the accuracy of robotic navigation. The first integrated procedures were conducted by Dr. Tamas Szili-Torok of Erasmus Medical Center in Rotterdam, The Netherlands.
“When you combine an advanced mapping technology that shows you the potential locations to treat the patient with a robotic technology that gets you there more rapidly, precisely and safely, you improve patient care and the physician experience simultaneously. Physicians are safer, patients are safer, and procedure time may be shortened with a potential for a reduced likelihood of additional procedures,” said Szili-Torok. “Integration of the technologies worked smoothly and provided an enhanced workflow. The procedures went very well, with successful treatment of patients with atrial arrhythmias in a safe and efficient fashion.”
AcQMap uses high-resolution ultrasound imaging and charge density mapping to create a visual display of the patient’s cardiac anatomy and arrhythmia conduction pattern in real time, informing ablation strategy beyond the pulmonary vein. Physicians can then use Stereotaxis’ RMN to steer the catheter according to their treatment strategy, allowing for precise guidance in areas of the heart that can be challenging to access. Physicians remain in a control room during the procedure, reducing radiation exposure.
“Precision is critical when treating cardiac arrhythmias. Understanding a patient's specific arrhythmia conduction pattern allows a physician to intuitively navigate an ablation catheter and treat the most challenging patients,” explained Vince Burgess, chairman, president and CEO of Acutus Medical. “We’ve created an integrated treatment option that prioritizes physician safety and leads to quality outcomes that improve lives. The ability to iteratively re-map in less than two minutes following each ablation step further enhances the appeal of this adaptive therapeutic approach. It's a winning solution that every hospital should provide.”
According to Stereotaxis’ website, “In traditional cardiac ablation procedures, a physician manually manipulates a catheter by hand. Controlling the catheter tip by holding on to the opposite end (three feet away!) while trying to perform precise movements within the delicate heart isn’t easy.”
RMN catheter navigation uses magnetic fields and robotic precision to navigate a magnetic catheter from the tip, as the website notes. The technology is comprised of two robotically-controlled magnets beside the operating table. During the procedure, a physician uses a computer interface to adjust the magnetic field around the patient. This allows the physician to precisely direct and steer the magnetic-tipped cardiac ablation catheter.
“The technology may seem like science fiction, but it is very much a reality. Hundreds of physicians at over one hundred leading hospitals globally have used this technology to treat over 100,000 patients to date,” the website continues. “The benefits of RMN are well established, with over 300 peer-reviewed scientific publications documenting the benefits of RMN.”
The AcQMap High Resolution Imaging and Mapping System detects and displays both standard voltage-based and higher resolution dipole density-based (charge-source) maps of the heart, combining ultrasound anatomy construction with an ability to map the electrical-conduction of each heartbeat to identify complex arrhythmias across the entire atrial chamber, according to Acutus. Following each ablation treatment, the heart can be re-mapped in seconds to continually visualize any changes from the prior mapping.
“The successful integration of the Stereotaxis and AcQMap systems allows physicians and patients to seamlessly receive the benefits of both world class technologies,” added David Fischel, chairman and CEO of Stereotaxis. “Using Stereotaxis’ robotic technology, electrophysiologists are able to enjoy the benefits of unparalleled patient and physician safety and exceptional catheter stability, all while seated away from the x-ray source in the control room. Our collaboration is premised on a shared vision that open ecosystems – stimulating collaboration and increasing choice – are positive for patients, physicians, providers, and medical progress.”
Acutus Medical also recently announced that the AcQMap High Resolution Imaging and Mapping System had been utilized for the first time in U.S. patients. The first procedure was successfully completed by Tim Betts, M.D., MBChB, FRCP at John Radcliffe Hospital, Oxford University Hospitals in Oxford, U.K.
“In patients undergoing re-do ablation for persistent AF we often need to look beyond simple pulmonary vein isolation and identify additional electrophysiological mechanisms driving the arrhythmia,” Betts pointed out. “In this particular patient, I was able to map both the left and right atriums, direct my ablation strategy at rotational activity and focal firing, and acutely terminate the longstanding persistent AF back to sinus rhythm. Seeing the System’s immediate impact has made me optimistic that this patient will now be free of AF.”
Acutus also announced the first enrollment in the RECOVER AF clinical study. The study is a single-arm, multi-center trial designed to provide clinical data regarding the use of the AcQMap System during first or second atrial fibrillation retreatment ablation procedures. The study will enroll up to 100 patients in Europe and Canada.
“Enabling physicians to see complex, irregular arrhythmias in real-time should provide important new insights and enable truly personalized and individualized ablation therapy planning. We hope that this unique capability, combined with the ability to quickly re-map after each ablation, will lead the way to further improvements in clinical outcomes for patients suffering from complex arrhythmias,” Burgess said in a press release.
