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Medtronic Drug-Eluting Coronary Stent Reimbursed in France

Medtronic has received reimbursement approval in France for its Endeavor drug-eluting coronary stent system. The stent is now available in all Western European markets. Last month, Medtronic presented clinical data at the Paris Course on Revascularization that demonstrated the long-term safety and efficacy of the Endeavor. Three- and two-year studies produced low rates of repeat procedures and major adverse clinical events.

Perhaps most compelling is that in all clinical trials to date, there have been no reported cases of late stent thrombosis in more than 1300 patients who have been followed for at least one year.

Although the Endeavor is not yet available in the United States, Medtronic filed a PMA module last October. However, the company doesn't expect to receive approval until the middle of 2007. Coronary disease is the leading cause of death in the United States. With such compelling clinical evidence, and so great a need for this product, why is it taking so long for FDA to approve it?

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