Patients implanted or considering being implanted with Abbott’s Ellipse implantable cardioverter defibrillator (ICD) can feel a little more relaxed about undergoing an MR scan, following the FDA’s approval of MR-conditional labeling for the device.

The Ellipse ICD with the Tendril MRI pacing lead, designed to monitor and help address abnormal heart rhythms, will now be manufactured with a list of suitable MR conditions, easing fears about the risks it may pose to patients during MR exams. Abbott’s Durata and Optisure high voltage leads will also now be available with MR-conditional labeling.

"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," said Mark Carlson, chief medical officer for Abbott's Cardiac Arrhythmias and Heart Failure division, in a press release. "By expanding our portfolio of MRI compatible devices, we're adding another benefit onto an ICD device that was designed hand-in-hand with physicians to optimize therapy for patients."
Many physicians are hesitant to perform MR exams on patients with implants that lack MR-conditional labeling, fearing that doing so could trigger MR-adverse events if the implant is incompatible with a specific model of MR scanner. Patients also worry about the risk of getting hurt because of their implants.

The Ellipse ICD also comes with other patient safety features as part of Abbott’s TailoredTherapy approach. These include its DeFT Response Technology, SecureSense and DynamicTx.

It also can capture and deliver therapy data to patient’s physician through the Merlin.net Patient Care Network, allowing doctors to assess their patient’s therapy and care remotely.

Patients implanted with the Ellipse ICD and Durata or Optisure leads prior to FDA clearance for labeling can also undergo MR exams.

The FDA previously approved MR-conditional labeling for Abbott’s Assurity MRI pacemaker and Tendril MRI pacing lead earlier this year.

Abbott is currently waiting for MR-conditional labeling approval of its Fortify Assura ICD and Quadra Assura CRT-D products, which are currently under FDA review.

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