Stereotaxis, Inc., a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that Takatsuki General Hospital, a leading acute care institution near Osaka, has reached the milestone of treating 120 patients using the Company’s Niobe® remote magnetic navigation system.
This milestone completes the required patient enrollment for the Niobe system’s post-market surveillance (PMS) in Japan. Reviewed by Japan’s Pharmaceutical and Medical Devices Agency (PMDA), the PMS is used to monitor the safety and effectiveness of medical devices once they are on the market. Upon completion of six-month patient follow-up, Stereotaxis and its local representatives will submit final study data to the PMDA to satisfy all PMS requirements.
Stereotaxis gained market entry of the Niobe system in Japan in 2013. Takatsuki General Hospital represents the first installed Niobe lab in Japan, performing initial procedures in July 2015. Led by Dr. Kohei Yamashiro, the hospital has adopted magnetic navigation as its key treatment option for complex cardiac arrhythmias, citing its increased safety and catheter precision as integral benefits, and has performed case demonstrations to visiting physicians and executives from many Japanese hospitals interested in magnetic navigation. Dr. Yamashiro has also been invited to present his clinical experience on magnetic navigation at several scientific conferences for electrophysiology, most recently at Japan Circulation Society (JCS) on March 20.
“Successful ablation requires precise catheter positioning, often in complex heart chamber anatomy,” said Dr. Yamashiro. “With the Niobe system’s computer-aided, magnetic catheter guidance, we have achieved precise steering for more accurate lesions and greater safety, as well as reduced radiation exposure to both patients and physicians. Our first 120 patients have realized outstanding acute success in the treatment of their arrhythmias, without any major complications.”