FDA gave MR-conditional labeling to two of Abbott's cardiac rhythm management (CRM) devices, a move that further boosts the company's ability to compete with its peers in the space.
The Abbott Park, IL-based firm said patients who receive a Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) or a Fortify Assura implantable cardioverter defibrillator (ICD) are now able to have an MRI in the future if need be. The Quadra Assura and the Fortify Assura are two of Abbott's most widely-used high voltage devices, the company noted.
In September 2016, Abbott won FDA approval for MR-conditional labeling for the Ellipse ICD, which represented the first major step toward closing an important gap that previously existed in St. Jude's portfolio, prior to Abbott and St. Jude merging.
"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," said Avi Fischer, MD, divisional vice president, medical affairs, and medical director of Abbott's CRM business. "We are excited to expand our portfolio and add MR-conditional labeling 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 MRI compatibility, Abbott's 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 also offers Abbott's MultiPoint Pacing and SyncAV technology to provide additional options for CRT patients who are not responsive to traditional cardiac resynchronization therapy. With MultiPoint Pacing, Abbott allows physicians to individualize CRT and shift their patient's treatment options from a single point of pacing to multiple options to better deliver therapy where needed. Abbott's SynvAV software allows a CRT device to detect real-time changes in a patient's cardiac condition and adjust therapy accordingly.
As with all Abbott cardiac rhythm management devices, all therapy data captured by the Fortify Assura and Quadra Assura MP devices can be wirelessly sent to a patient's doctor through the Merlin.net Patient Care Network.