New FDA approvals for Abbott’s MRI-ready devices

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MRI-ready devices approved by FDA

Abbott has announced the US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for the Quadra Assura MP cardiac resynchronisation therapy defibrillator (CRT-D) and Fortify Assura implantable cardioverter defibrillator (ICD), two of the company’s most widely-used high voltage medical devices.

The approvals follow recent MR-conditional labelling approvals for the Assurity MRI pacemaker, Ellipse ICD and associated MRI-compatible leads, and further expand Abbott’s portfolio of MRI-ready devices for patients indicated for ICDs and/or CRT-D devices who may need an MRI in the future.

 

In 2017, the FDA amended their recall statement of certain models of Fortify Assura and Quadra Assura MP, to include Abbott’s new alert system which warns against potential rapid battery depletion. The company recently acquired St. Jude Medical, where the devices were developed.

For some patients, the potential need for a future MRI has made MR-conditional labelling important as physicians assess therapies and device options. As a result, Abbott has done extensive testing to demonstrate that these devices are safe in the most commonly-used MRI scanners, developing their range of MRI-ready devices.

“For many patients who need an ICD or CRT-D device, receiving a device that is MRI-ready is a key benefit that can ensure future access to MRIs—an important and commonly-used diagnostic tool,” says Avi Fischer, divisional vice president, medical affairs, and medical director of Abbott’s cardiac rhythm management business. “We are excited to expand our portfolio and add MR-conditional labelling to the Fortify Assura ICD and Quadra Assura MP CRT-D to provide patients and their physicians additional peace of mind if those patients need an MRI in the future.”

In addition to being MRI-compatible, the Fortify Assura ICD and Quadra Assura MP CRT-D also include the company’s suite of TailoredTherapy features, which are designed to provide physicians additional flexibility and control in how they deliver therapy to treat their patient’s cardiac arrhythmias and congestive heart failure, even as their patient’s therapy needs change over time. With the TailoredTherapy feature set, the Fortify Assura ICD and Quadra Assura MP CRT-D help protect against the delivery of unnecessary therapy and continuously evaluate the condition of a lead to consistently deliver appropriate therapy. Combined with MRI compatibility, these features offer physicians additional options to leverage when managing patient care.

The Quadra Assura MP CRT-D is a multi-point pacing MRI-ready device equipped with Abbott’s SyncAV technology, to provide additional options for CRT patients who are not responsive to traditional cardiac resynchronisation therapy. With their MultiPoint Pacing tachnology, Abbott allows physicians to “individualise” cardiac resynchronisation therapy and shift their patient’s treatment options from a single point of pacing to multiple options to better deliver therapy where needed. Abbott’s SyncAV software allows a CRT device to detect real-time changes in a patient’s cardiac condition and adjust therapy accordingly.

Data captured by the devices can be directly, securely and wirelessly sent to a patient’s doctor through an online network and app developed by Abbott. This communication allows physicians to remotely monitor their patient’s therapy and assess any need for intervention.

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