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.
Source: www.medicaldevice-network.com; June 12, 2013.