• BIO27514_Acticor_7_HF_T_QP
  • BIO27515_Acticor_7_HF_T
  • BIO27514_Acticor_7_HF_T_QP
  • BIO27515_Acticor_7_HF_T

    Acticor HF-T/HF-T QP

    Detect Early. Monitor Reliably. Improve Outcomes. 

    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 Technology is the only single-lead ICD system providing true atrial sensing. Utilizing a floating atrial dipole, DX ICDs allow physicians to identify, assess and reliably monitor a patient’s AF burden and subsequent disease progression over time. 

    Category

    CRT-D Cardiac Resynchronization

    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 monitor3 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.4, 5

    DX Technology Detect Early

    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).3,9
    • 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.9
    • 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
    DX Technology Monitor Reliably

    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.4,5 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 duration3
    • 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 manner4,5
    DX Technology Improve Outcomes

    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.3,9,10

    • When AF burden becomes significant in DX ICD patients, the most common intervention is prescribing OAC.9
    • In the THINGS study, incidence of OAC onset was twice as high in the DX group compared to the traditional single-chamber ICD group.9
    • 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.10

    Product Detail

    • Features MRI AutoDetect technology, which can automatically recognize when the patient enters an MRI environment and convert the device to MRI mode. When the scan is complete, MRI AutoDetect automatically returns the device to its permanent program.
    • BIOTRONIK ProMRI6 systems increase patient access to MRI scanning and give physicians more options to choose from without any compromise on therapy.
    • Atrial Diagnostics and SVT Discrimination.
    • Dual-chamber discrimination with SMART Detection® - the only sophisticated discriminator that also works on redetection.
    • Reduced lead complications - dual-chamber ICDs have a 40% increased risk in peri-operative complications and 45% increased risk in hospital mortality.7
    • Reduced procedure complexity - less implant time compared to dual-chamber.8
    • Elimination of cost for atrial lead.

    Related Information

    Downloads & Related Links

    Manual Library ProMRI System Check ProMRI Configurator

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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. 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.;
      4. 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.;
      5. 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.;
      6. For combination of MR conditional devices, please see the "ProMRI MR conditional device systems" manual.
      7. Dewland TA et al. J Am Coll Cardiol. 2011, 58(10).
      8. Sticherling C et al. Circ Arrhythm Electrophysiol. 2011, 4(1).
      9. 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.;
      10. 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