FDA approves Ellipse and SJM Assura ICDs and CRT-Ds (St Jude Medical) for Heart Failure
The FDA has approved the next-generation Ellipse and SJM Assura portfolio of implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), from St Jude Medical, for use in patients with Heart Failure. The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery. Additionally the 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. These devices recieved CE mark approval in the EU in April 2012.
Learning Zones
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