The Minnesota device maker said that it had informed physicians that the problem affected several models of the QuickSite and QuickFlex Left Ventricle leads used in cardiac resynchronization therapy pacemakers and defibrillators. Physicians were told that about 3 percent to 4 percent of leads exhibited this defect, although there has been no death or serious injury reported from the 39 cases of the so-called externalized conductors. Roughly 101,000 QuickSite and QuickFlex LV leads are in use worldwide.
Lead abrasion issues have been plaguing the company recently with the U.S. Food and Drug Administration classifying a similar physician advisory of the Riata and Riata ST implantable cardioverter defibrillator leads as a Class I recall. A recent study found 22 deaths associated directly to those leads. It remains to be seen how the FDA classifies the QuickSite and QuickFlex advisory.
Many are doubting the safety of the newer, Durata line of ICD leads because they are similar in design to the Riata leads. However, St. Jude CEO Daniel Starks has declared that the company’s newer ICD leads have a proprietary coating that is 50 times more resistant to lead abrasion than older leads that have silicone insulation. In fact, St. Jude has stopped making ICDs with silicone-only insulation.
A St. Jude spokeswoman confirmed Wednesday that with the withdrawal of the QuickSite and QuickFlex CRT leads, there is no device on the market with the silicone insulation.