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www.fdanews.com/articles/98045-let-the-des-recovery-begin

Let the DES Recovery Begin

September 5, 2007

Drug eluting stents (DES) were first launched in April 2003. By 2005, the category was racking up sales of $3.1 billion. Then, in September 2006, studies presented at the European Society of Cardiology meeting reported potential problems with thrombosis following DES implants. These studies generated significant media attention which, in turn, led to an FDA hearing on the subject and a congressional review of off-label marketing that included DES practices. As a result, DES sales in the second quarter of 2007 were 42 percent lower than during the same period in 2006.

As The Wall Street Journal reports, however, the market might be on the verge of a turnaround. Ironically, the spark that may relight DES activity comes from the European Society of Cardiology meeting, the same place where the all bad news started in 2006. The latest research indicates that when compared to bare metal stents, DES have a 1 percent higher mortality rate instead of the 18 percent originally reported.

The primary rationale for DES use is restenosis, a re-narrowing of the artery which occurred to a high degree after bare metal stent implantation. Since the restenosis problem hasn’t gone away, the new research showing comparable mortality rates between the two types of stents should go a long way towards increasing comfort levels when choosing DES.