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|St. Jude Medical Announces FDA Approval of High-Voltage Devices with New Safety Features|
Next-generation implantable defibrillators feature additional safety features to address common lead complications
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.
“The new safety features in these devices are an excellent example of
innovation that improves patient safety,” said Dr.
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.
“St. Jude Medical strives to deliver the highest levels of patient
safety. The new Ellipse ICD and SJM Assura family of devices support
those efforts by providing added features that ensure effective therapy
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 Ellipse ICD provides all of the industry-leading 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.
An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). Approximately 325,000 people per year in the U.S. die suddenly of SCD.
A CRT-D device resynchronizes the beating of the heart's lower chambers
(ventricles), which often beat out of sync in heart failure patients,
and provides back up treatment for SCD, which is a risk factor
associated with certain types of heart failure. Studies have shown that
CRT (cardiac resynchronization therapy) can improve the quality of life
for many patients with heart failure, a progressive condition in which
the heart weakens and loses its ability to pump an adequate supply of
blood. About five million Americans suffer from heart failure, with
550,000 new cases diagnosed every year, according to the
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