St. Jude Medical’s “Externalisation” Woes Extend To QuickSite and QuickFlex LV CRT Leads

In short

St. Jude Medical, Inc. has announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite® and QuickFlex® Left-Ventricular (LV) Leads, used to connect Cardiac Resynchronization Therapy (CRT) devices to the heart.

Background

In a press release, which can be found here, the company informs us that it has issued a physician letter in which it has sought to deal with the risk of externalisation of lead conductors in its QuickSite and QuickFlex LV leads. It notes that “there have been only 39 confirmed cases of externalized conductors, out of 171,000 leads sold worldwide. However, based on its own analysis, the company estimates that 3-4% of QuickSite and QuickFlex leads “may exhibit externalized conductors.”

St. Jude will no longer sell these lead models, although it observes that the overall safety and reliability of QuickSite and QuickFlex leads continues to be comparable to currently available CRT leads from other manufacturers.

This medical device advisory does not affect the company’s continued sale of its newer QuickFlex µ (micro) or Quartet® LV leads, which are fully insulated using Optim® insulation along the entire length of the lead body. There have been no reports or observations of externalized conductors in these newer Optim-insulated leads, out of over 65,000 of these leads sold worldwide since 2008.

Helpfully the company informs us that a conductor externalisation can be visualized on an x-ray or fluoroscopic image; however, these cables are protected by an additional layer of insulation, and therefore can continue to function properly if an externalization occurs.

Source: St Jude Medical, Business Wire