COLORADO SPRINGS, Colo., Oct. 18 -- The Spectranetics Corp. has received regulatory approval from the Japanese Ministry of Health and Welfare to market its laser and various sizes of its Extreme and VitesseC coronary catheters in Japan.
Spectranetics worked with its Japanese distributor, Heiwa Bussan Co., Ltd., to obtain the Japanese regulatory approval. Heiwa Bussan, founded in 1946, is a well-established medical instrument distributor in Japan specializing in the import and sale of products for the cardiovascular field.
Joseph A. Largey, president and chief executive officer of Spectranetics, said the approval has great significance for Spectranetics because the Japanese market for interventional cardiology is the third largest in the world, after the United States and Europe. He said the company began, upon approval, to incrementally sell the equipment to a few Japanese doctors who were already trained to use the equipment, but that it won't aggressively sell products in Japan until it receives reimbursement approvals in about a year.