News | May 16, 2013

St. Jude Medical Gains CE Mark for Ellipse and SJM Assura Defibrillators

Implantable defibrillators feature additional safety features aimed to elevate the standard of care

May 16, 2013 — St. Jude Medical Inc. has received CE Mark approval of its Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new portfolio is designed to lower the risk for lead abrasion and to ensure high-voltage therapy delivery.

The Ellipse and SJM Assura family of devices 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, the Ellipse and SJM Assura portfolio of implantable defibrillators features low-friction coating on the device can, which has been demonstrated in testing to significantly reduce the friction between the device and leads. As such, the low-friction coating is designed to reduce the risk for lead-to-can abrasion, the most common type of lead insulation failure in the industry.

These technologies provide preventative and adaptive capabilities to address potential failures that can result in the inability to deliver high-voltage therapy when needed, especially in systems using silicone-only insulated defibrillation leads, which are known to be at higher risk of abrasion.

“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.”

The Ellipse and SJM Assura devices also feature expanded protection against inappropriate and unnecessary shocks with SecureSense RV Lead Noise Discrimination, an algorithm that expands St. Jude Medical ShockGuard Technology. SecureSense RV Lead Noise Discrimination differentiates lead noise (over-sensing of electrical signals) from true ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes requiring therapy.

The Ellipse ICD provides all of the features offered by the Fortify Assura ICD inside the smallest volume, high-voltage device on the market. The Ellipse ICD allows for 36 J in delivered energy, providing a downsized option without compromising on energy, longevity, safety or reliability.

The Assura family of devices allows St. Jude Medical to continue to offer 40 J in delivered energy and includes the Quadra Assura CRT-D, the Unify Assura CRT-D and the Fortify Assura ICD.

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