Cordis Corporation, a Johnson & Johnson company, has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to market its CYPHER sirolimus-eluting coronary stent in Japan.
CYPHER stent distribution in Japan is expected to begin mid-year 2004, coincident with government approval of reimbursement. Japan is the world's second largest interventional cardiology market with approximately 166,000 angioplasties performed annually, 70% of which involve stent placement.
"The CYPHER stent will provide Japanese interventional cardiologists with an important new tool to safely treat coronary artery disease," said Akira Matsumoto, President, Johnson & Johnson K.K. "We will be working closely with Japanese physicians to optimise patient outcomes with the CYPHER stent."
The CYPHER stent is Japan's first approved drug-device combination to significantly reduce the incidence of restenosis of a treated coronary artery - one of the greatest challenges in long-term management of patients with heart disease. The CYPHER stent has been shown to reduce restenosis by 90% compared with a conventional bare metal stent.
"Cordis is very pleased to bring this breakthrough technology to physicians and patients in Japan," said Guy Lebeau, a Johnson & Johnson Company Group Chairman who has worldwide management responsibility for Cordis Corporation. "Clinical evidence and worldwide experience with more than 600,000 patients treated to date demonstrates the safety and effectiveness of the CYPHER stent and its ability to dramatically improve the lives of patients."
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