St. Jude Medical gets CE mark status for new device portfolio

9 May 2013 (Last Updated May 9th, 2013 18:30)

Global medical devices major St Jude Medical has received CE mark status for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).

St. Jude Medical

Global medical devices major St Jude Medical has received CE mark status for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).

The company said that the new portfolio of devices has been developed to minimise the risk for lead abrasion and support high-voltage therapy.

By using the DynamicTx over-current detection algorithm, the devices adjust shocking configurations automatically, thereby ensuring the delivery of high-voltage therapy in the event of an electrical short in one portion of the system.

St Jude Medical Implantable Electronic Systems division president Dr Eric Fain said the goal for the portfolio is to take implantable defibrillation reliability and patient safety to the next level.

"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," Fain said.

The Ellipse and SJM Assura family of devices were also integrated with SecureSense RV lead noise discrimination, which shields inappropriate and undesired shocks by differentiating lead noise from true ventricular tachycardia or ventricular fibrillation (VF) episodes needing therapy.

A low-friction coating on the implantable defibrillators is expected to reduce the risk for lead-to-can abrasion, which is considered the most common type of lead insulation failure in the industry.

The company said the devices help in addressing all potential failures in systems using silicone-only insulated defibrillation leads that pose a higher risk of abrasion.

Jessa Hospitals in Hasselt, Belgium director of electrophysiology Dr Johan Vijgen said; "The annual rate of lead defects increases over time regardless of manufacturer and insulation failure accounts for 70% of lead failures in older leads".


Image: St Jude Medical says the new portfolio would help minimise the risk for lead abrasion and ensure high-voltage therapy delivery. Photo: Courtesy of St Jude Medical.