Release date: 2017-02-09
Recently, Abbott announced that the US FDA approved magnetic resonance (MR) conditional labels for the company's Assurity MRI pacemaker and Tendril MRI pacing lead. Patients implanted with these low voltage devices will have a safe possibility of performing a whole body magnetic resonance imaging (MRI) scan, if needed. With this approval, the Assurity MRI pacemaker is now the world's smallest, longest-lived wireless MRI-compatible pacemaker.
A pacemaker is a small, low-voltage implantable device that sends electrical pulses to the heart if the heart beats too slowly. The pacemaker can monitor heart rate (its beat rate or speed) and rhythm (it beats mode) and provide electrical stimulation when the heart beats too slowly. Pacemakers can alleviate the symptoms of dizziness and fatigue caused by slow-paced rhythms and help patients enjoy a better quality of life. More than 4 million people worldwide have implanted pacemakers or other heart rhythm management devices, and about 700,000 new patients receive these devices every year.
â–² Assurity MRI pacemaker schematic (Source: prnewswire)
A lead is a thin insulated wire that is placed through a vein and into the heart as part of a pacemaker implantation procedure. The tip of the lead is attached to the heart tissue and the other end is connected to the pacemaker. The lead transmits electrical pulses from the pacemaker to the heart and transmits information from the heart back to the implant device. Some pacemakers are referred to as "MR conditions" or "MR compatible." This means that they are designed to allow patients to perform MRI scans safely under certain conditions. By implanting a pacemaker that allows MRI scans, patients can access many diagnostic tools that doctors consider to be their first choice. MRI scans are considered to be the most informative imaging modality for providing medical professionals with the diagnosis of patients because they provide very detailed images and have a low radiation risk.
â–² Tendril? MRI pacing lead diagram (Source: sjmglobal)
Abbott works with world-renowned electrophysiologists, clinicians and hospital administrators to develop a variety of innovative pacemakers. Among them, Abbott's Assurity MRI pacemakers also provide wireless remote monitoring, giving doctors the ability to securely access their patient diagnostic data and daily device measurements, and reduce the need for physician office access. Remote monitoring for heart disease patients has been a best practice for the past decade, and research continues to demonstrate its positive impact on patient outcomes and reduced healthcare costs. In 2015, the Heart Rhythm Society developed wireless remote monitoring as standard care in its guide.
Allowing patients to undergo MRI scan pacemakers is gradually coming out, and it has become a significant advancement for patients who may have such needs in the future. During an MRI scan, the Assurity MRI pacemaker works with Abbott's MRI ActivatorTM handheld device to trigger individualized pre-programmed MRI settings for the patient. This unique technology can help eliminate many of the inconveniences associated with time and patient, often associated with routine pre- and post-scan pacemaker reprogramming.
Abbott continues to build its portfolio of MRI-labeled products and is actively working with regulatory agencies around the world to ensure that many of its most common implantable pacemakers, implantable cardioverter defibrillators (ICDs) and heart re Synchronous therapy (CRT) equipment obtains label approval for MR conditions.
Avi Fischer, Medical Director of Abbott’s Cardiac Rhythm Management Business, said: “Our mature Tendril MRI pacing lead (more than 200,000 patients worldwide) and the latest MR conditional label for our Assurity MRI pacemaker are approved. Helps provide diagnostic procedures for patients while providing the product performance that physicians need, ultimately providing the best care for their patients."
Reference material
[1] Abbott Announces US Approval for its Assurity MRI? Pacemaker, the World's Smallest, Longest-Lasting Wireless MRI-Compatible Pacemaker
[2] Abbott official website
Source: WuXi PharmaTech (Wei Signal WuXiAppTecChina)
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