Originally Posted by
wiggin
ABSORB is the name of the product; it is made by Abbott. New clinical data just came out in the last few weeks that casts yet more doubt on the efficacy and safety of the stent compared to the newest metal drug-eluting stents.
CE Mark is not easy to get, but in general the requirements are laxer than for the FDA - the FDA requires bigger, better clinical studies with longer timepoints (typically companies will get approval in Europe first and use data from the European roll-out to get FDA approval). There are exceptions, though, since each class of devices and drugs is regulated differently and there are some faster tracks available at the FDA. The clinical data available when this product got the CE Mark was just ridiculously small sample size and short term follow up. Given that the current gold standard treatment was pretty damned good (this was a non-inferiority design rather than a superiority design) there was no reason to fast-track approval for something so new and with so many serious questions about how it would work in the long term clinically. In this particular case, IMO it borders on negligence.
The FDA is sometimes to restrictive and cautious, and that is incredibly frustrating (and drives up costs). But we've seen far too many times that their caution is warranted when new classes of therapies come out and end up performing quite poorly.
