Singapore, Dec 15, 2009: According to Millennium Research Group (MRG), an authority on medical technology market intelligence, Japan's complex regulatory environment and lengthy device approval process has created a significant lag in peripheral vascular stenting device availability in the country compared to other developed nations.

 

MRG's new Japanese Markets for Peripheral Vascular Devices 2010 report finds, however, that recent indication-specific device approvals in Japan will drive peripheral vascular stent procedures to expand at a compound annual growth rate of 11% over the next five years, a step up from the 6% annual growth experienced from 2008 to 2009.

 

In 2008, the Japanese Ministry of Health, Labour and Welfare granted regulatory approval and reimbursement for Cordis' PRECISE, Japan's first vascular stent indicated for the treatment of carotid artery stenosis. That same year, Japan's first embolic protection device, Cordis' ANGIOGUARD, was also approved for use in conjunction with its carotid stent. Both ev3 and Boston Scientific are expecting to launch their carotid stents and embolic protection devices in Japan sometime in 2010.

 

In 2009, Cordis was again first to receive regulatory approval for use of its PALMAZ GENESIS balloon-expandable stent in the renal artery indication. Because reimbursement is not provided for procedures where stents are used off-label, these indication-specific approvals enable physicians to get reimbursed for these stent procedures, thereby promoting procedure adoption and market growth.

 

"Although the off-label use of peripheral vascular stents occurs in Japan, this is not common practice due to the strict regulatory environment, as well as the high cost associated with the use of these devices off-label," says Darren Navarro, Analyst at MRG.

 

"Because the approval process for a device can take upwards of several years, some devices will continue to be used off-label due to the lack of approved devices for specific indications. Over the next few years, it is expected that more indication-specific stents will emerge in Japan to meet the growing demand for peripheral vascular stenting in the carotid, renal, and other vascular indications, including the lower extremities," adds Darren Navarro.