Technology and Device Management
These documents describe an IRB-approved research study and clinical safety workflow that allows patients with pacemakers/ICDs (CIEDs) to undergo clinically indicated MRI with standardized monitoring, device programming, and follow-up, while…
Read MoreThis patient-facing educational handout explains the process, risks, and safeguards involved when patients with legacy (non–MRI-conditional) pacemakers or implantable cardioverter defibrillators (ICDs) undergo MRI imaging. It is designed to support…
Read MoreThis patient-facing educational handout provides clear, step-by-step guidance to help reduce infection risk and support optimal recovery for patients undergoing implantable cardiac device procedures. Designed for use before pacemaker, ICD,…
Read MoreThe Cardiocases website provides example device tracings and useful explanations to help clinicians improve their skills. The content is provided in English and French – just click on the appropriate…
Read MorePresentations and Graphics: In this slideshow presentation, the learner will explore the mission and history of the FDA and Center for Device and Radiological Health (CDRH), how the CDRH and FDA contribute to a device’s classification, approval, and post-approval maintenance, and an overview of the Total Product Lifecycle Advisory Program Pilot.
Read MorePresentations and Graphics: In this presentation, the learner will explore the purpose and structure of a medical device advisory committee, how they function, and recent guidance.
Read MorePresentations and Graphics: Slideshow presentation that explores collaborative communities, early feasibility studies, and the EP EFS initiative.
Read MorePresentations and Graphics: Slideshow presentation that explore what an investigational device exemption is, significant risk versus non-significant risk device studies, and how IRB’s and the FDA factor in to decisions around device studies.
Read MorePresentations and Graphics: Succinct presentation slides exploring heart rhythm device recalls, FDA’s roles and responsibilities relating to recalls, and recall communications. Also includes risk assessment and mitigation for recalled devices.
Read MoreJournal Articles: Atrial fibrillation (AF) is the most common cardiac arrhythmia diagnosed and treated in the world. The treatment of patients’ symptoms as well as the prevention of stroke and heart failure is dependent on accurate detection and characterization of AF. A variety of electrocardiographic (ECG) monitoring techniques are being used for these purposes. However, these intermittent ECG monitoring techniques have been shown to underdiagnose AF events while having limited ability to characterize AF burden and density. Continuous long-term implantable loop recorder (ILR)–based ECG monitoring has been designed to overcome these limitations. This technology is being increasingly used to diagnose episodes of AF in high-risk patients and to improve characterization of AF episodes in patients with known AF. This review aims to review the potential clinical utility of ILR-based ECG monitoring while highlighting some inherent limitations of the current technology. An understanding of these limitations is important when considering the use of ILR-based ECG monitoring and clinical decision making based on the information being stored within these devices.
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