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For St. Jude Medical, this latest revelation comes at a difficult time as physicians are still trying to deal with the management of St.Jude's earlier-generation recalled silicone defibrillator leads, the Riata and Riata ST. The revelation that this externalization can now affect St. Jude's bradycardia left ventricular pacing leads will no doubt affect physician's device selection. It is also clear that St. Jude Medical's portfolio of products for their lucrative cardiac rhythm management division will be significantly impacted.
For patients with these left ventricular pacing leads, follow-up of their system may involve x-ray evaluation on an intermittent basis, but I do not think that St. Jude and its physician advisory board will recommend removal of these leads, given the risks of infection and trauma that might be inherent to that procedure.
More likely, careful routine follow-up of these leads will be all that is required for now with the addition of at least one surveillance x-ray evaluation of the patient's LV lead and RV lead systems.
4 Apr 2012 @ 10:55 am CST: Updated to include photo.
Disclaimer: Please understand that the opinions expressed in this blog are mine alone and do not represent the views of St. Jude Medical nor NorthShore University HealthSystem. I have no financial ties with St. Jude Medical but do serve on the speaking circuits for Medtronic, Boston Scientific, and Zoll Medical.