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    DX Technology

    DETECT EARLY. MONITOR RELIABLY. IMPROVE OUTCOMES.

    The Only Single-Lead ICD System Providing True Atrial Sensing  

    Atrial fibrillation (AF) is a widespread, often silent problem for implantable cardioverter-defibrillator (ICD) patients, occurring at an annual incidence of nearly 21%.1 Unfortunately, it is difficult or even impossible to detect with a standard, single-chamber ICD.1 If AF remains untreated, a patient’s clinical condition may worsen, potentially resulting in severe outcomes. 

    DX ICDs help detect atrial arrhythmias early2, allowing patients at risk to be identified and enabling prompt, appropriate management. Only DX Technology combines a single tachy lead with the ability to offer direct atrial sensing in ICD patients, providing atrial diagnostics that have led to a variety of therapeutic interventions across multiple studies3,4,5

    Category

    Tachycardia ICD

    Product Highlights

    DX Technology Detect Early

    Detect Early

    DX ICDs increase the likelihood of detecting atrial arrhythmias early compared to single-chamber ICDS,2 helping you to identify patients at risk and enabling prompt, appropriate patient management.

    DX Technology Monitor Reliably

    Monitor Reliably

    DX Technology allows you to assess and reliably monitor4 AF burden as well as subsequent disease progression over time.

    DX Technology Improve Outcomes

    Improve Outcomes

    Since DX Technology can detect and monitor AF burden, appropriate therapy can be initiated in a timely manner for improved clinical outcomes.6,7

    Clinical Evidence

    More Than a Decade of Clinical Experience

    DX Technology Related Information

    More Than a Decade of Clinical Experience

    DX Technology boasts a long-standing history of clinical experience and a vast body of clinical evidence. Since 2009, over 100,000 implantations⁸ have been performed in more than 80 countries⁸, supported by over 20 clinical studies involving more than 4,000 patients.⁹

    This strong foundation of clinical evidence has recently been enriched by the MATRIX study results, the largest clinical evaluation of DX Technology to date.⁴
    >20
    clinical studies
    >4,000
    study patients
    >100,000
    devices implanted

    Detect Early

    • Only DX Technology combines a single tachy lead with the ability to offer direct atrial sensing in ICD patients. Combined with BIOTRONIK Home Monitoring®, DX Technology provides device diagnostics in a timely manner, allowing physicians to detect atrial arrhythmias early.2

      • DX provides a direct, true atrial signal thanks to the DX lead enhanced with a floating atrial dipole.
      • DX is proven to provide long-term stable atrial sensing (24-month follow-up period).2,3,4
      • The DX ICD is nearly four times more likely to detect subclinical AF than with a standard single-chamber ICD in patients without a history of atrial arrhythmias at implant.3
      • DX ICDs have shown superior AHRE detection rates compared to traditional single chamber ICDs, and equivalent detection rates to dual-chamber ICDS (AHRE detection rates: DX: 13%, VR-ICD: 5.3%, DR-ICD: 13%)2
    The SENSE Trial
    DX Technology Detect Early

    Monitor Reliably

    • Once AF is detected, quantification of AF burden becomes critically important for timely intervention, supported by the AHA/ACC/HRS and European Society of Cardiology (ESC) guidelines on AF management.6,7 Because of its unique atrial sensing capabilities and comprehensive diagnostics, the DX ICD system correctly classifies atrial arrhythmias and quantifies AHRE burden.

      • DX allows for a correct estimation of AF burden with reliable classification of AHRE episodes by their duration4
      • DX helps healthcare professionals adhere to the AHA/ACC/HRS and ESC guidelines on AHRE monitoring and initiate OAC treatment for stroke prevention in a timely manner6,7
    The MATRIX Trial
    DX Technology Monitor Reliably

    Improve Outcomes

    • The early detection and reliable monitoring of AHRE episodes can provide the diagnostic information needed to inform intervention strategies. Atrial diagnostics provided by DX have led to a variety of therapeutic interventions across multiple studies.3,4,5

      • When AF burden becomes significant in DX ICD patients, the most common intervention is prescribing OAC.3
      • In the THINGS study, incidence of OAC onset was twice as high in the DX group compared to the traditional single-chamber ICD group.3
      • In the REACT DX study, 69% of DX patients with no history of AF and new-onset AHRE detection had OAC initiated within an average of 24 days.5
    The THINGS Registry
    DX Technology Improve Outcomes

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    References

    1. Reinhold T, Belke R, Hauser T, et al. Cost Saving Potential of an Early Detection of Atrial Fibrillation in Patients after ICD Implantation. BioMed Research International, Volume 2018, 14 August 2018, Article ID 3417643.
    2. Thomas G, et al. Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter-defibrillator systems: Results of the SENSE trial. Journal of Cardiovascular Electrophysiology, Volume 30, Issue 10, October 2019, Pages 1994–2001.
    3. Biffi M, Iori M, De Maria E, et al. The role of atrial sensing for new-onset atrial arrhythmias diagnosis and management in single-chamber implantable cardioverter-defibrillator recipients: Results from the THINGS registry. Journal of Cardiovascular Electrophysiology, Volume 31, Issue 4, April 2020, Pages 846–853.
    4. Hindricks G, Theuns DA, Bar-Lev D, et al. Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole. EP Europace, 2023, 00, 1-10.
    5. O’Connor M, et al. “REACT DX Registry: Real world reaction to atrial high-rate episodes detected in implantable cardioverter-defibrillator recipients with a DX lead” Technology And Health Care 2023;31:735-746
    6. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal, Volume 42, Issue 5, 1 February 2020, Pages 373–498.
    7. January C, Wann LS, et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. Circulation. 2019;140:e125-e151.
    8. Data on file, status January 2024
    9. Based on completed studies with a focus on evaluating DX Technology. Further DX recipients are included in ongoing studies or studies with broader scope.