St. Jude Medical won CE Mark approval for its Ellipse and Assura lines of implantable cardiac devices. The implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are designed to deliver high voltage current to cardiac tissue while reducing abrasion from the electrode leads thanks to a new coating.
Additionally, the devices feature an improved algorithm, called SecureSense, which prevents unnecessary shocks and makes sure those delivered are appropriate for the situation.
From St. Jude:
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 next-generation Ellipse and SJM Assura portfolio of implantable defibrillators feature 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 advanced 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. It is estimated that over 400,000 silicone-only insulated defibrillation leads from all manufacturers remain active worldwide.
The Ellipse and SJM Assura family of 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.