The approval, which follows a successful three-year clinical trial of the Niobe technology at the Tokyo Women’s Medical University, will enable the company to commence marketing efforts in the country.
Stereotaxis board of directors chairman William Mills said, "Our entry into Japan provides opportunity for meaningful growth in the Asia Pacific region and marks a major step towards our vision of becoming the first choice in the treatment of complex electrophysiology ablations for the global marketplace."
The company said that there are currently 570 hospitals in Japan performing approximately 38,000 electrophysiology (EP) procedures annually, 45% of which are atrial fibrillation (AF) cases.
Niobe technology, which has demonstrated efficiency in reducing radiation exposure to physicians and patients, will be particularly appealing to a Japanese society highly sensitive to radiation risk, according to Mills.
Stereotaxis’ technologies include Niobe ES Remote Magnetic Navigation system, the Odyssey portfolio of lab optimization, networking and patient information management systems and the Vdrive Robotic Mechanical Navigation system and consumables.
