On 25 March, Stereotaxis announced that it received regulatory approval of its Niobe remote magnetic technology for cardiac ablations in Japan.
The company announced that this approval will allow Stereotaxis to begin marketing efforts, including establishing a local business infrastructure with in-country distributors, while working on obtaining reimbursement approval for full market entry, or the ability to initiate sales. Reimbursement approval is expected by the end of 2013.
Approval by the Pharmaceuticals and Medical Devices Agency, Japan’s equivalent to the US Food and Drug Administration, follows a successful three-year clinical trial of the Niobe system at the Tokyo Women’s Medical University. The clinical trial was led by Morio Shoda and supported by the company’s industry collaborators in Japan.
“An aging population, prominent cardiovascular institutions that embrace new technologies and favorable, universal health coverage create a very attractive environment for us to leverage our one-of-a-kind robotic navigation system,” said William Mills, chairman of the Stereotaxis board of directors. “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.”
Mills adds that Niobe demonstrated strength in significantly reducing radiation exposure to physicians and patients will be particularly appealing to a Japanese society highly sensitive to radiation risk. The company looks forward to showcasing its Niobe technology for prospective Japanese clients at the annual Heart Rhythm Society (HRS) scientific session in May and the Japanese HRS meeting in July.