This just in. I was doing an endovascular case today in a patient with a chronic total occlusion (CTO) of the femoral artery. After crossing the total occlusion, I needed to re enter the true lumen after being unsuccefful with my glide wire (Terumo) and Quik Cross (Spectranetics). I called for my "go to tool" which is my device of choice for me in this cirumstance. Only to find out that Cordis Endovascular/Johnson and Johnson has pulled the Outback re entry device from the market. More information will be forthcoming, however it appears that this is a proactive voluntary recall because of a .27% incidence of failure of the piercing needle component to safely retract. I'll corroberate that information in future posts.
The description of the event that triggered the recall was previously described in an FDA post in March, 2007.
For more information about chronic total occlusion (CTO) and methods of intervening upon these challenging lesions read this review article at vascular disease management.
The question that arises is will this affect level of success for CTO treatment because this is a commonly used device or will alternative devices such as the Pioneer device (Medtronic Vascular) fill the void.
Thanks for the sharing of those article! That will be helpful.*
Posted by: coach factory outlet | October 31, 2010 at 11:58 PM