St. Jude Medical won FDA approval for the new Ellipse and Assura lines of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These devices are capable of creating more powerful electric shocks than other cardiac implants and helps prevent abrrasion thanks to a low friction coating. The defibrillators also feature St. Jude’s SecureSense technology that improves the detection capabilities of implants to deliver fewer unnecessary shocks.
The same St. Jude devices were approved in Europe only last month.
The Ellipse and SJM Assura family of devices feature the DynamicTx™ Over-Current Detection Algorithm, which automatically adjusts shocking configurations to ensure the delivery of high-voltage therapy even 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 have a 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 provides an extra layer of insulation and 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 have also featured 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. These features also are capable of providing remote patient alerts over the Merlin.net™ Patient Care Network (PCN); a secure, Internet-based remote care system for patients with implanted medical devices.
The St. Jude Medical high-voltage portfolio is augmented by the Durata™ defibrillation lead with Optim™ lead insulation. With more than 11,000 leads actively monitored in prospective, active registries and more than 29,000 lead-years of data, independently analyzed by the Population Health Research Institute, the Durata lead is the most studied lead on the market and continues to demonstrate excellent performance.