• BIO27527_Rivacor_7_HF_T_QP
  • BIO27527_Rivacor_7_HF_T_QP

    Rivacor 7 HF-T QP/HF-T

    More Life. Made Simpler.

    Simplified and optimized CRT for up to 9 years1

    Heart failure is tough to live with and can be complex and time-consuming to treat and manage. It’s these real life challenges that Acticor 7 CRT-D systems are engineered to deal with. These new and smaller systems simplify treatment and therapy for up to 9 years1, and when used with BIOTRONIK Home Monitoring technology, they have been clinically proven to help prolong life further30.

    Category

    CRT-D Cardiac Resynchronization

    Product Highlights

    9 Years Longevity. 6 Years Warranty.

    9 Years Longevity. 6 Years Warranty

    Acticor CRT-Ds have an extended battery life of 9 years9, supported by a full 6-year warranty

    Full 3T MRI. Autodetected.

    Full 3T MRI. Autodetected

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

    Continuous CRT Optimization.

    Continuous CRT Optimization

    All these beneficial technologies are also available with unique CRT-DX technology that provides complete atrial diagnostics without an atrial lead

    9 Years Longevity. 6 Years Warranty.

    Acticor CRT-Ds have an extended battery life of 9 years9, supported by a full 6-year warranty.

    • Acticor CRT-Ds live up to 9 years and are the smallest, slimmest 3T FBS devices that live that long10
    • 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.

    • For CRT patients, who already face a higher risk burden, increased device longevity can reduce the number of replacements. These patients are exposed to higher risk of complication than single- or dual-chamber ICD patients11
    • Saving a replacement can lead to lower risk and less distress for CRT patients
    • Fewer replacements means reduced procedure costs. At the same time, complication-related costs can be avoided by reducing risks resulting from replacements

    Full 3T MRI. Autodetected.

    All Acticor 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 mass12.

    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 through 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 required13.

    Continuous CRT Optimization.

    Acticor 7 CRT-D features CRT AutoAdapt:

    • Every minute, CRT AutoAdapt automatically adjusts to changes in the patient’s condition, thus providing continuous CRT adaptation and allowing for more personalized response.
    • Automatic AV delay optimization focus on clinically relevant intrinsic timing.
    • Automatic selection of paced chambers based on A-RV and A-LV conduction patterns.
    • By reducing pacing to LV-only, battery life can reach up to 10.8 years, even with daily remote data transmission12
    BIOshape Ultraslim Icon

    BIOshape. Ultraslim 10mm CRT-D.

    Acticor CRT-Ds  are small and slim — only 10mm from front to back — with a smooth, elliptical, and body-friendly BIOshape1.

    • Acticor CRT-Ds are the smallest, slimmest devices that are approved for 3T full-body MRI scans2 

    BIOshape eases implantation and reduces skin pressure3,4.  It helps to lower the risk of skin erosion while increasing patient comfort5.

    • 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 models6
    • 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 with previous models8
    Mortality Reduction Icon

    More Than 60% Mortality Reduction

    Heart failure is a serious and progressive condition that puts CRT patients at risk in multiple ways. For these patients, AF is a common cause for loss of CRT pacing, while hospitalization for decompensation is a frequent concern. Therefore, clinical guidelines recommend close multiparameter monitoring, because time is of the essence.

    When CRT-Ds are used with BIOTRONIK Home Monitoring, life can be further prolonged with a clinically-proven > 60% reduction in all-cause mortality14.

    • Early detection of clinically relevant events through BIOTRONIK Home Monitoring enables early intervention15
    • The IN-TIME trial shows that all-cause mortality can be reduced by >60%16. This outcome can be achieved by following the IN-TIME protocol, based on daily transmissions
    • BIOTRONIK Home Monitoring can be easily programmed to IN-TIME settings, enabling 28 alerts with the click of a button. This avoids the hassle of manually adjusting the alert settings to trigger ‘IN-TIME events’

    Home Monitoring works via a smartphone-size, ‘plug in and go’ CardioMessenger Smart mobile unit, which is quick and easy to use17 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 involvement18, 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%19,20
    • 99% of patients agree that BIOTRONIK Home Monitoring is easy to use, while 98% express their complete satisfaction with the system21

    QuickCheck gives access to patient data typically within 3 to 4 minutes22 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 minutes23
    • 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
    DX Technology Icon

    DX Technology

    All these beneficial technologies are also available with unique CRT-DX technology that provides complete atrial diagnostics without an atrial lead.

    • BIOTRONIK's proprietary CRT-DX technology provides unique atrial sensing capabilities with a floating atrial dipole integrated into the RV lead
    • For patients not requiring atrial stimulation, CRT-DX systems provide AV-synchronous CRT pacing with only two leads
    • No atrial lead means less hardware, which can lead to lower risk, fewer complications, reduced costs and shortened procedure and fluoroscopy time

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      References

      1. Contoured housing; Acticor/Rivacor CRT-D QP: 60x75x10mm; 35ccm; CRT-D: 60x71.5x10mm; 33ccm; 2. as part of an MR conditional system; 3. Post-Market observation; interim-analysis, December 21, 2018. Data on file; 4. Device shape analysis, February 2019. Data on file; 5. Post-Market observation; interim-analysis, December 21, 2018. Data on file; 6. Post-Market observation; interim-analysis, December 21, 2018. 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 HF-T QP, 9.3 years @ 60 ppm; RA 15%, RV/LV 100% pacing, RA/RV/LV @ 2.5 V/0.4 ms; 500 Ohms, 2 max. energy shocks/year. Data on file; 10. Acticor/Rivacor HF-T QP: 9.3 years @ 60 ppm; RA 15%, RV/LV 100% pacing, RA/RV/LV @ 2.5 V/0.4 ms; 500 Ohms, 2 max. energy shocks/year: Data on file vs. Medtronic 3T FBS; CLARIA (AMPLIA, COMPIA) MRI QUAD CRT-D SureScan: 6.8 years; Competitor device manuals as of Nov. 2018; 11. Lee DS et al. Evaluation of Early Complications Related to De Novo Cardioverter Defibrillator Implantation. Insights From The Ontario ICD database. J Am Col Cardiol 2010; 55:774-82; 12. Fact file: Cardiac Imaging with MRI, CT and Nuclear Techniques, British Heart Foundation. January 2010; 13. When patients are monitored by BIOTRONIK Home Monitoring. See ProMRI® manual for all details;14. 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; 15. 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; 16. 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; (3.4% in the Home Monitoring Group vs. 8.7% in the control group); 17. Ricci R P et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace (2010) 12, 674-679; 18. Ricci R P et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace (2010) 12, 674-679; 19. 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; 20. Vs. 55% - Crossley G H, Boyle A, Vitense 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]; 21. Ricci R P et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace (2010) 12, 674-679; 22. Performance analysis. Data on file, 2018; 23. Performance analysis. Data on file, 2018; 24. Martin DO et al. Heart Rhythm 2012;9(11):1807-1814; 25. van Gelder BM, Bracke FA, Meijer A, Pijls NH. The hemodynamic effect of intrinsic conduction during left ventricular pacing as compared to biventricular pacing. J Am Coll Cardiol 2005;46:2305–2310; 26. Acticor/Rivacor HF-T QP, 10.8 years @ 60 ppm; RA 15%, RV 0%, LV 100% pacing, RA/RV/LV @ 2.5 V/0.4 ms; 500 Ohms, 2 max. energy shocks/year. Data on file; 27. Post-Market observation; interim-analysis, December 21, 2018. Data on file; 28. QP models only; 29. Post-Market observation; interim-analysis, December 21, 2018. Data on file; 30. 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; (3.4% in the Home Monitoring Group vs. 8.7% in the control group).