Although they have been available in the US for a while, peripheral vascular (PV) plugs have only recently emerged as a product of interest in the transcatheter embolization and occlusion (TEO) device space. In particular, the recent FDA approval of St. Jude Medical's AMPLATZER Vascular Plug 4 has brought attention to these devices in the US. This most recent plug is smaller and therefore capable of treating more conditions, which will positively affect the total volume of TEO procedures. It is also anticipated to cannibalize the use of PV coils to some extent traditional pushable coils are hard to reposition, which is a handy feature of PV plugs. Although more recent detachable coils are also repositionable, procedures using these coils tend to be considerably more expensive than procedures using PV plugs. As a result, the market potential for PV plugs is looking pretty good in fact, way better than anyone would have predicted a year ago.
It is interesting though that St. Jude has yet to attain FDA approval for the AMPLATZER Plug 3, which is available in Europe. Possibly St. Jude was sidetracked integrating AGA Medical the company that originally developed the AMPLATZER plug after its 2010 acquisition and didn't have the time or resources to push products through the tedious FDA process. But let's face it, the AMPLATZER Plug 3 received CE marking in Europe in 2008long before the acquisition so it seems likely that the AMPLATZER Plug 3 is a victim of the slow and expensive FDA process that we've heard so much about
More details on the use of PV plugs in the US can be found in our most recent TEO device report.