FIRM BREAKS INTO JAPANESE MARKET AFTER NINE-YEAR APPROVAL PROCESS
As the Japanese regulatory landscape shifts toward shorter approval times, one firm recently emerged from a nine-year process to tell its tale of what it takes to get a device into the Japanese market.
Cook's Zenith endovascular graft received approval in Japan July 11 -- the first such device to break through a regulatory system in flux, the firm said.
The Zenith device is used during endovascular repair, where two small incisions are made in the groin to insert catheters that are guided to the site of the aneurysm. Once in place, the catheters deploy a self-expanding endograft constructed of polyester surgical graft material.
The Japanese have been using "homemade" devices for a long time, said Barry Thomas, who heads Cook's global endovascular therapies division. Competitors such as Medtronic and Baxter are still waiting for the Japanese government to give their endovascular devices the thumbs up, he added.