FDAnews
www.fdanews.com/articles/81477-guidant-launches-heart-stent-system-in-japan

GUIDANT LAUNCHES HEART STENT SYSTEM IN JAPAN

October 7, 2005

Guidant recently launched its Multi-Link Vision RX Coronary Stent System in Japan after receiving the Japanese government's regulatory and reimbursement approvals. This new stent system uses cobalt chromium, which is stronger and more radiopaque than stainless steel, allowing these devices to be thinner without compromising visibility, the company said.

Japan's Ministry of Health, Labor and Welfare recently approved the device in coronary vessels, in 8 mm to 28 mm lengths. The system has demonstrated positive clinical results, with a 1.9 percent target lesion revascularization and a 15.7 percent binary restenosis rate at six months.

"The MULTI-LINK VISION RX offers excellent clinical results for the treatment of coronary artery disease," noted Greg Davis, president of Guidant, Japan K.K.