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St. Jude receives FDA clearance for next-generation Ellipse, SJM Assura devices

St. Jude Medical, a medical device manufacturer, has received US Food and Drug Administration (FDA) approval for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

The next generation portfolio of devices is designed to lower the risk of lead abrasion and ensure delivery of high-voltage therapy.

The Ellipse and SJM Assura portfolio of devices feature the DynamicTx over-current detection algorithm, which adjusts shocking configurations automatically to allow the delivery of high-voltage therapy even when an electrical short occurs in one segment of the system.

The portfolio of implantable defibrillators also features a low-friction coating on the device can, which reduces the friction between the device and leads during tests to a great extent. A low-friction coating provides an extra layer of insulation and is intended to lower the risk for lead-to-can abrasion, which is a regular kind of lead insulation failure.

These devices address potential failures due to the inability to provide high-voltage therapy when required, particularly in systems using silicone-only insulated defibrillation leads, which are at higher risk of abrasion.

Moreover, the new devices are equipped with expanded protection against unnecessary shocks through the SecureSense RV lead noise discrimination, an algorithm that builds upon the company’s current ShockGuard technology.

St Jude Medical Implantable Electronic Systems Division president Dr Eric S Fain said that the company 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 delivery," Fain said.