FDA approval for MRI-compatibility for Ellipse ICD

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Abbott has received US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for one of the company’s most widely-used implantable cardioverter defibrillators (ICD) and associated high voltage leads. The approval of MR-conditional labelling for the Ellipse ICD with the Tendril MRI pacing lead and Durata and Optisure high voltage leads will help further improve access for patients suffering from abnormally fast heart rhythms who need an ICD and who may need an MRI scan in the future.

The new MR-conditional labelling for the Ellipse ICD allows patients to undergo an MRI scan if needed. In addition, patients previously implanted with an Ellipse device and Durata or Optisure leads can now undergo MRI scans.

“When you consider the number of patients each year who rely on the lifesaving treatment delivered by an ICD device, it is critical to continually innovate to provide new benefits to people battling complex arrhythmias and other cardiac conditions,” says Mark Carlson, chief medical officer for Abbott’s Cardiac Arrhythmias and Heart Failure division. “By expanding our portfolio of MRI compatible devices, we are adding another benefit onto an ICD device that was designed hand-in-hand with physicians to optimise therapy for patients.”

The smaller shape and size of Ellipse ICD helps improve patient comfort once implanted and Abbott engineered the device with features designed to optimise ICD therapy and improve patient safety. The features, known as Abbott’s TailoredTherapy approach, include:

  • DeFT Response Technology: Allows physicians to adapt how therapy is delivered by the Ellipse ICD to ensure each patient receives therapy based on their unique need. The feature also helps ensure successful therapy delivery without the need to deliver an initial shock at the time of implant.
  • SecureSense: Abbott’s SecureSense algorithm offers an additional level of protection for patients by providing proper sensing within the heart even in the presence of external interference (known as “lead noise”) to safeguard against unnecessary therapy being delivered to the patient.
  • DynamicTx: With Abbott’s DynamicTx algorithm, physicians can be confident that their patient’s devices are consistently evaluating the condition of the lead and adapting the path of the electrical impulse to deliver appropriate therapy.

As a further benefit, all therapy and other data captured by the Ellipse ICD can be directly, securely and wirelessly sent to a patient’s physician through the Merlin.net Patient Care Network. This communication allows physicians to remotely monitor their patient’s therapy and assess any need for intervention.

The latest labelling ensuring Ellipse ICD is MRI ready follows approval earlier this year of the Assurity MRI pacemaker and prior MR-conditional labelling approvals in Europe, allowing Abbott to further build its portfolio of MRI ready products. The company continues to work with regulatory agencies around the world to secure approval for MR-conditional labelling for additional commonly-implanted pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) devices.

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