St. Jude Medical (St. Paul, MN) has been under the watchful eye of the FDA for its Durata ICD leads. While these leads have been well-scrutinized, a new independent analysis shows that these defibrillator leads are 100 percent safe from mechanical failure and abrasion after five years. St. Jude Medical hopes that the latest results will help the company remain competitive.
For the independent analysis, The Population Health Research Institute compiled patient data from three different registries. Data was compiled for the Durata and Riata ST Optim. The analysis found that the leads had a 99.4 percent rate of freedom from mechanical failure and a 99.9 percent rate of freedom from insulation abrasion.
These leads by St. Jude Medical include a specialized Optim polymer insulation. This insulation includes technology from AorTech. St. Jude Medical states that this technology can help reduce the risk of corrosion that resulted in some patient deaths and a Riata recall in 2011.
“St. Jude Medical is proud to sponsor the largest actively monitored lead performance evaluation ever conducted for an ICD lead family,” stated Dr. Mark Carlson, a vice president at St. Jude Medical. “We are pleased that PHRI’s independent analysis of our Optim-insulated lead registries continues to demonstrate the excellent safety and reliability of our Durata ICD leads.