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June 11, 2013

St Jude Medical receives FDA clearance for next generation of high-voltage devices

Global medical device company St Jude Medical has received clearance from the US Food and Drug Administration (FDA) for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).

By Shalini Nair

SJM

Global medical device company St Jude Medical has received clearance from the US Food and Drug Administration (FDA) for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).

This new family of devices is aimed at lowering the risk of lead abrasion and ensuring delivery of high-voltage therapy to patients.

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 next-generation 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 advanced 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.

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.

The new devices also come with expanded protection against unnecessary shocks through the SecureSense RV lead noise discrimination, an algorithm that builds upon the company’s existing ShockGuard technology.

SecureSense RV differentiates lead noise – the over-sensing of electrical signals – from true ventricular tachycardia or ventricular fibrillation episodes requiring therapy.

These features also are capable of providing remote patient alerts over the Merlin.net patient care network – an internet-based remote care system for patients with implanted medical devices.


Image: St Jude Medical has introduced next-generation implantable defibrillators that feature additional safety features to address common lead complications. Photo: Courtesy of St Jude Medical.

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