St. Jude Medical (St. Paul, MN) landed CE Mark approval from the European Union for a cardiac resynchronization therapy defibrillator and an implantable cardioverter defibrillator. The regulatory approval covers both the SJM Assure and Ellipse CRT-Ds and ICDs. The devices contain several upgrades that help improve the delivery of high-voltage therapy. In addition, the devices contain improvements that reduce the amount of friction between the devices and their leads. Reduced friction can help cut back on lead insulation failure.
Lead insulation failure has been a challenging issue for St. Jude Medical. While the company recalled its Riata ICD leads, it still faces several lawsuits. The lawsuits allege that a poorly designed lead caused device failure and inappropriate shocks.
Durata leads have also been under fire. While Durata was touted as a safer alternative, concerns over manufacturing and longevity issues with the device. In January of this year, the FDA sent a warning letter to St. Jude Medical over manufacturing problems at its Durata plant. The letter stated that agency would not approve export requests or PMAs for devices from the facility until problems listed in the warning letter were addressed.
“The new Ellipse ICD and Assura family of devices demonstrates St. Jude Medical’s commitment to developing technologies that provide physicians with advanced patient management tools to mitigate the most common ICD lead complications, especially those that can lead to ineffective high voltage therapy delivery,” stated Dr. Eric Fain, president of the Implantable Electronic Systems Division at St. Jude Medical.