Posted 3/26/12 on Cracking Health Costs
We’re seeing a trend. The FDA approves a stent without proper testing. Death and complication rates with the new stent increase, the FDA is force to review it.
Remember the controversy over drug eluding stents?
According to an article in the WSJ by Thomas Burton, the so-called Stryker stent…aka the Wingspan device… is increasing rates of death of patients who have received them. Following protocol a panel has been convened. According to the WSJ article, “The FDA had asked the outside panel to advise it on what to do in the wake of a large study last year showing more strokes and deaths in patients with the Wingspan device than among those whose condition was treated using drugs.”
Further, “Researchers in the study concluded the rate of stroke in the patients who got the Wingspan device was ‘substantially higher than the rates previously reported
with the use of the Wingspan stent.’ ”
This is yet another reason for patients to be cautious in agreeing to a stent, and another reason employers need to consider favoring clinics who practise strict evidence-based medicine constructs.