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St. Jude Medical Gets FDA Approval For Ellipse And SJM Assura Family Of Devices

Medical device maker St. Jude Medical, Inc. (STJ) said Tuesday that the U.S. Food and Drug Administration has approved the company's next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators.

The new devices are designed to lower the risk of 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 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.

Those 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.

by RTTNews Staff Writer

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