Abbott Expands Portfolio of MRI-Ready Devices

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,...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news