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 in order to ensure the delivery of high-voltage therapy even if an electrical short occurs in one portion of the system.
The portfolio of implantable defibrillators also has a low-friction coating on the device can, which has proved to significantly reduce the friction between the device and leads during tests.
A low-friction coating offers an additional layer of insulation and is meant to lower the risk for lead-to-can abrasion, which is the most common kind of lead insulation failure.
Offering preventative and adaptive capabilities, these devices address potential failures that can result in the inability to deliver high-voltage therapy when required, particularly in systems using silicone-only insulated defibrillation leads, which are known to be at higher risk of abrasion.
The new devices also come equipped with expanded protection against unnecessary shocks through the SecureSense RV lead noise discrimination, an algorithm that builds upon the company's existing 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.
