CE Mark For St.Jude’s Next-Generation Ellipse and SJM Assura ICD/CRT-Ds

In short

St. Jude Medical, Inc. has gained CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The company says its new portfolio is designed to lower the risk for lead abrasion and to ensure high voltage therapy delivery.

Background

Hot on the heels of Medtronic’s announcement of FDA approval for its latest CRT-D and ICD devices comes St.Jude trumpeting the CE mark for its Ellipse and SJM Assura devices.

Both St.Jude’s newly approved systems feature the DynamicTx™ Over-Current Detection Algorithm, which automatically adjusts shocking configurations within the device to ensure the delivery of high-voltage therapy if an electrical short in one portion of the system were to occur.

In addition, they feature low friction coating on the device can, which has been demonstrated in testing to significantly reduce the friction between the device and leads, reducing the risk for lead-to-can abrasion, the most common type of lead insulation failure in the industry.

Physician comments

“The annual rate of lead defects increases over time regardless of manufacturer and insulation failure accounts for 70 percent of lead failures in older leads,” said Johan Vijgen, M.D., director of electrophysiology at Jessa Hospitals in Hasselt, Belgium. “With important safety features designed to ensure successful delivery of high-voltage therapy, these new devices offer my patients a higher standard of care.”

Company comments 

“The goal for this innovative portfolio of devices is to bring implantable defibrillation reliability and patient safety to the next level,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “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.”

Full release here.

Source: St.Jude Medical, Inc., Business Wire