• Rivacor 7 VR-T
  • Rivacor 7 DR-T
  • Rivacor 7 VR-T DX
  • Rivacor 7 VR-T
  • Rivacor 7 DR-T
  • Rivacor 7 VR-T DX

    Rivacor 7 VR-T / DR-T

    More Life. Made Simpler.

    Improving treatment and reducing risk for up to 15 years1

    For patients with arrhythmias, ICD therapy can be an essential safety net, where it’s vital to minimize risk and improve quality of life in the long term. This is what the all-new, smaller and simpler Rivacor 7 ICD systems are engineered to do for up to 15 years1 — optimizing therapy when and where it matters. When used with Home Monitoring® technology, AF can be detected earlier2 and both inappropriate shocks and hospitalization rates can be reduced3. And this has been clinically proven.

    Category

    ICD Tachycardia

    Product Highlights

    Ultraslim

    BIOshape. Ultraslim 10mm ICD

    Rivacor ICDs are small and slim – only 10mm from front to back – with a smooth, elliptical, and body-friendly BIOshape4

    Longevity

    15 Years Longevity. 10 Years Warranty

    Rivacor ICDs have an extended battery life of up to 15 years1, supported by a full 10-year warranty

    DX Technology Berry 95

    DX Technology

    All these benefits are also available with unique DX Technology that provides complete atrial diagnostics with a single lead

    BIOshape. Ultraslim 10mm ICD

    Rivacor ICDs are small and slim — only 10mm from front to back — with a smooth, elliptical, and body-friendly BIOshape4.

    • Rivacor ICDs are the smallest, slimmest devices that are approved for 3T full-body MRI scans5.

    BIOshape eases implantation6 and reduces skin pressure7.  It helps to lower the risk of skin erosion while increasing patient comfort6.

    • The smooth, elliptical form facilitates insertion procedures. On average, four out of five implanting physicians rated ‘ease of device insertion’ and ‘securing in the pocket’ as ‘better’ or even ‘much better’ than with preceding models8.
    • Thinner design and rounded edges reduce skin pressure7 and help to lower the risk of skin erosion.
    • Over 90% of implanting physicians rated ‘patient comfort’ as ‘better’ or even ‘much better’ in comparison to previous models6.

    15 Years Longevity. 10 Years Warranty

    Rivacor ICDs have an extended battery life of up to 15 years1, supported by a full 10-year warranty.

    • Rivacor ICDs live up to 15 years and are the smallest, slimmest 3T FBS devices that live that long9.
    • Extended warranty reduces financial risk for implanting clinics, as fewer devices for replacement procedures will need to be purchased.

    This can lead to fewer box replacements and fewer procedures for patients, reducing risks, complications and costs.

    • Fewer replacements means less distress for patients. The higher the remaining life expectancy, the more device replacements avoided.
    • A lower number of required replacements also means lower risk of infection10.
    • Fewer replacements also means reduced procedure costs. At the same time, complication-related costs can be avoided by reducing risks resulting from replacements. The higher the patient’s life expectancy is at implantation, the higher the potential cost savings.
    DX Technology Berry 150

    DX Technology

    All these benefits are also available with unique DX Technology that provides complete atrial diagnostics with a single lead.

    • With DX ICDs, almost four times more likely to detect AT/AF than with a standard single-chamber ICD.11, 12, 13, 14
    • Reliable detection and transmission of atrial high-rate episodes (AHRE) with clinically relevant duration (for AHRE ≥1 hour, positive predictive value [PPV] >99.7%).15 
    • Correct estimation of AF burden with reliable classification of AHRE episodes by their duration.15
    • Incidence of oral anticoagulation (OAC) prescription onset tends to be higher with DX ICDs compared to standard single-chamber ICDs. 12
    MRT Autodetect 150 Berry

    Full 3T MRI. Autodetected

    All Rivacor devices feature ProMRI®, which gives full and uncompromised access to high-resolution MRI, with full-body scanning and no exclusion zone.

    • 3 Tesla MRI offers the best image quality, required for example for neuroimaging. This standard significantly reduces scanning time and increases hospital efficiency.
    • Full-body MRI means no exclusion zone and hence allows for the assessment of the cardiac anatomy, function and mass16.

    MRI AutoDetect senses MRI environments and self-adjusts, suspending tachycardia therapy for the duration of the scan only. This can be activated with a single visit to the physician and has a 14-day window for planning.

    • MRI AutoDetect is a sensor-based technology that ensures optimal therapy and simplifies workflows in MRI.
    • Upon activation, MRI AutoDetect automatically recognizes an MR environment for up to 14 days. It provides the shortest time in MRI mode possible by automatically switching in and out of MRI mode. This minimizes tachycardia therapy suspension to the duration of the actual scan.
    • MRI AutoDetect can be active for up to 14 days, allowing for multiple scans and scheduling flexibility regarding time and location. It provides a complete Home Monitoring report after the scan, meaning only one in-office visit is required17.
    Inappropriate Shocks 150 Berry

    90 % Fewer Inappropriate Shocks

    ICD patients face risks associated with increased atrial burden. While atrial arrhythmias are known to be the most frequent cause of inappropriate shocks in transvenous ICDs, they also increase the risk for hospitalization and can lead to worsening of heart failure.

    BIOTRONIK Home Monitoring helps physicians detect AF earlier2. It reduces the number of inappropriate shocks by 90%3 and related  hospitalization rates by 73%3.

    • The TRUST trial clearly shows that BIOTRONIK Home Monitoring enables physician evaluation of arrhythmias more than 30 days earlier2. This allows physicians to better manage atrial burden18.
    • In ECOST, a randomized study with 433 patients, BIOTRONIK Home Monitoring was highly effective in the long-term prevention of inappropriate shocks. The number of inappropriate shocks was 90% lower as compared to control3.
    • As a consequence of reducing inappropriate shocks through BIOTRONIK Home Monitoring, the number of hospitalized patients was significantly reduced by 73%3.

    Home Monitoring works via a smartphone-sized, ‘plug in and go’ CardioMessenger Smart mobile unit, which is quick and easy to use19 and transmits data without any patient involvement.

    • BIOTRONIK's 'plug in and go' solution allows for user-friendly system initialization. Data transmission is completely automatic, not requiring any active patient involvement19, while the smartphone-sized CardioMessenger Smart transmitter makes BIOTRONIK Home Monitoring a mobile system.
    • Daily, system-based transmission checks allow for industry-leading transmission success rates of 85%20,21.
    • 99% of patients agree that BIOTRONIK Home Monitoring is easy to use, while 98% express their complete satisfaction with the system19.

    QuickCheck gives access to patient data typically within 3 to 4 minutes6 for more efficient treatment and greater peace of mind for patients.

    • QuickCheck provides fast access to patient data. Upon the physician’s request in the Home Monitoring Service Center, data typically becomes available within 3 to 4 minutes6.
    • Patient device data can be transmitted without patient interaction.
    • This allows clinicians to be responsive to patients' needs remotely, while patient satisfaction may be positively influenced by the knowledge that the physician has access to current cardiac device data.
    • Immediate clarification and patient reassurance might be complemented by a scheduled visit (for instance, on the next day), reducing the need for spontaneous hospital visits.

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    Manual Library ProMRI SystemCheck ProMRI Configurator

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      References

      1. Single-Chamber ICD, Standard conditions, Rivacor 7 VR-T, RV: 2.5 V/0.4 ms, 40 bpm, 500 Ω; RV: 15 % pacing; 2 max. energy shocks/year; Home Monitoring: ON (daily transmission); diagnostics: ON. Data on file (Calculation of service times).; 2. Varma N et al. Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up: The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial. Circulation, 2010;122: 325 – 332.; 3. Guedon-Moreau L et al. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol, 25 (2014), 763-770.; 4. Contoured housing; Acticor/Rivacor VR: 60x61.5x10 mm; 30 ccm.; 5. As part of an MR conditional system.;  6. Post-Market observation; Final report, March, 2019. Data on file.; 7. Device shape analysis, February 2019. Data on file.; 8. Post-Market observation; Interim-analysis, December 21, 2018. Data on file.; 9. Acticor/Rivacor Single-chamber ICD @ 60 ppm, 15% pacing, 2.5V, 500 Ohms: Medtronic 3T Full-body MRI; VISIA AF (EVERA; MIRRO) MRI S VR SureScan: 10.7 years (MDT IFU) vs Acticor 7 VR-T ProMRI: 14.9 years. Competitor device manuals as of Nov. 2018.; 10. Polyzos KA, Konstantelias AA, Falagas ME, Risk factors for cardiac implantable electronic device infection: A systematic review and meta-analysis, Europace (2015) 17, 767-777.; 11. In patients without a history of atrial arrhythmias at implant.; 12. 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.; 13. Pung X, Hong DZ, Ho TY, et al. The utilization of atrial sensing dipole in single lead implantable cardioverter defibrillator for detection of new-onset atrial high-rate episodes or subclinical atrial fibrillation: A systematic review and meta-analysis. Journal of Arrhythmia. Volume 38, Issue 2, 15 January 2022, Pages 177–186.; 14. Thomas G, Choi DY, Doppalapudi H, 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.; 15. 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, Volume 25, Issue 5, May 2023, Pages 1-10, euad061.; 16. Fact file: Cardiac Imaging with MRI, CT and Nuclear Techniques British Heart Foundation. January 2010.; 17. When patients are monitored by BIOTRONIK Home Monitoring. See ProMRI manual for all details.; 18. Schwab JO et al. Clinical Course of Dual-Chamber Implantable Cardioverter-Defibrillator Recipients followed by Cardiac Remote Monitoring: Insights from the LION Registry. BioMed Research International, 2018, https://doi.org/10.1155/2018/3120480.; 19. Ricci R P et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace (2010) 12, 674-679.; 20. Hindricks G et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. The Lancet. 2014; 384 (9943): 583–590.; 21. Crossley G H et al. The CONNEXT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) Trial. JACC. 2011; 57(10):1181-1189 [for bar chart comparison only].