MINNEAPOLIS, Minnesota — Medtronic expects in May to enter the Japanese market with its brand of drug-eluting coronary stent after recent approval by the Japanese government, according to a company release.
It will be a new opportunity for the Endeavor stent system as it struggles with competition in the United States. One device analyst declared to Dow Jones News Service last month that Endeavor was an “also ran.”
Japan is the last major untapped market for Endeavor in the $4 billion global stent sector. With its recent approval by the Japanese Ministry of Health, Labor and Welfare, Endeavor’s final hurdle will be a government reimbursement authorization on May 1. Medtronic will begin selling Endeavor immediately after that approval, the company stated.
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The Endeavor was approved in Europe in 2005 and by the U.S. Food and Drug Administration in February 2008. That FDA approval triggered a surge in Medtronic’s domestic stent sales and the device grabbed an estimated 19 percent of U.S. market share.
But Abbott Laboratories’s Xience stent has helped push Endeavor’s domestic market share back to about 10 percent.
Also, a study presented this weekend found that Johnson & Johnson’s Cypher stent was more effective and at least as safe as either Medtronic’s or Boston Scientific’s products. The report included some good news for Medtronic, which partially funded the study.
The study showed that Boston Scientific’s new Taxus Liberte stent had at one year a 14.2 percent combined rate of events, which included death, heart attacks and retreatment in the same blood vessel, Dow Jones reported. Endeavor’s combined rate was 10.1 percent and Cypher’s was 8.3 percent.
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The difference between Endeavor and Cypher was not statistically significant, according to the study. However, the difference between those devices and Taxus Liberte was considered significant.
