Stereotaxis has announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has classified its Niobe Magnetic Navigation System as a C2 medical device.
The C2 classification recognises the Niobe system as a new, distinctive technology with clinical benefits and is the highest of five reimbursement categories for medical devices in Japan. The MHLW also approved reimbursement for two electrophysiology ablation catheters compatible with Niobe magnetic navigation, effective 1 October 2013.
Japan’s MHLW, which controls the country’s reimbursement rates, will establish a more permanent “technical fee” for procedures using the Niobe system during its biennial review of insurance reimbursement pricing for C2 devices before 1 April 2014. Until then, the MHLW authorised a temporary “technical fee” of 343,700 yen (approximately US$3,500) per Niobe procedure, which the company says sufficiently covers the costs associated with Niobe’s disposable unit for catheter advancement (QuikCAS).