Rivacor 7 DR-T/VR-T
More Life. Made Simpler
Improving treatment and reducing risk for up to 15 years
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 years – optimizing therapy when and where it matters. When used with Home Monitoring technology, AF can be detected earlier and both inappropriate shocks and hospitalization rates can be reduced. And this has been clinically proven.
BIOshape. Ultraslim 10mm ICD
Rivacor ICDs are small and slim – only 10mm from front to back – with a smooth, elliptical, and body-friendly BIOshape.
- Rivacor ICDs are the smallest, slimmest devices that are approved for 3T full-body MRI scans.
BIOshape eases implantation and reduces skin pressure. It helps to lower the risk of skin erosion while increasing patient comfort.
- 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 models.
- Thinner design and rounded edges reduce skin pressure 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 models.
15 years longevity. 11 years warranty
Rivacor ICDs have an extended battery life of up to 15 years, supported by an industry leading 11-year warranty.
- Rivacor ICDs live up to 15 years and are the smallest, slimmest 3T FBS devices that live that long.
- 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 infection.
- 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.
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 mass.
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 required.
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 earlier. It reduces the number of inappropriate shocks by 90% and related hospitalization rates by 73%.
- The TRUST trial clearly shows that BIOTRONIK Home Monitoring enables physician evaluation of arrhythmias more than 30 days earlier. This allows physicians to better manage atrial burden.
- 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 control.
- As a consequence of reducing inappropriate shocks through BIOTRONIK Home Monitoring, the number of hospitalized patients was significantly reduced by 73%.
Home Monitoring works via a smartphone-sized, ‘plug in and go’ CardioMessenger Smart mobile unit, which is quick and easy to use 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 involvement, 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%,.
- 99% of patients agree that BIOTRONIK Home Monitoring is easy to use, while 98% express their complete satisfaction with the system.
QuickCheck gives access to patient data typically within 3 to 4 minutes 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 minutes.
- 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.
All these benefits are also available with unique DX technology that provides complete atrial diagnostics with a single lead.
- BIOTRONIK's proprietary DX technology provides dual-chamber diagnostics that combines unique sensing capabilities with a floating atrial dipole in a single-lead system. While functioning without an atrial lead, DX devices are able to detect AF.
- DX technology provides a more complete IEGM that enables better clinical decision making.
- By delivering dual-chamber SVT discrimination, it reduces inappropriate therapy.
Rivacor 7 ICD & CRT
Family More Life. Made Simpler
Now CE marked
1 Contoured housing; Acticor/Rivacor VR: 60x61.5x10 mm; 30 ccm
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 Single-Chamber ICD Standard conditions. Data on file (service time calculation)
10 Acticor/Rivacor Single-Chamber ICD @ 60 ppm, 15% pacing, 2.5V, 500 Ohms: Medtronic 3T FBS; 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
11 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.
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(R) manual for all details.
14 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.
15 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.
16 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.
17 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.
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 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.
20 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.
21 Ricci R P et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace (2010) 12, 674-679.
22 Ricci R P et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace (2010) 12, 674-679.
23 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
24 vs. 55% - 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]
25 Ricci R P et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring. Europace (2010) 12, 674-679.
26 Performance analysis. Data on file, 2018
27 Performance analysis. Data on file, 2018
28 Kurt M et al. Avoiding inappropriate therapy of single-lead implantable cardioverter defibrillator by atrial-sensing electrodes. Journal of Cardiovasc. Electrophysiol. 2018; 29(12): 1682-1689