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Amvia Sky DR-T/SR-T
The Amvia Sky pacing system gives you choices. Take advantage of a broader range of treatment options, including physiologic pacing and tools to address development of atrial fibrillation (AF).
As the first pacemaker to be approved for a left bundle branch area pacing approach (LBBAP)1, Amvia Sky fosters natural myocardial contraction patterns in your patients. It provides physiologic heart rates with Closed Loop Stimulation (CLS) and aims to maintain sinus rhythm with Atrial ATP (aATP).
At the same time, Amvia Sky automates many routine tasks during implantation, in-office follow-ups, remote monitoring, and MRI workflows. Deliver unique physiologic pacing to your patients, enhance therapy, and free up time in daily workflows – so that more patients may benefit from more personalized care.
Product Highlights
Achieve Physiologic Pacing
Amvia Sky is the first pacemaker approved for left bundle branch area pacing (LBBAP).1 Moreover, Amvia Sky's unique Closed Loop Stimulation (CLS) sensor technology follows the autonomic nervous system and adapts automatically2 to mimic the natural intrinsic regulation.3
Manage Atrial Arrhythmias
Amvia Sky aims to help patients maintain physiologic heart rates over time. It combines in-office and remote atrial monitoring capabilities with the arrhythmia management tools of Atrial ATP (aATP) to actively address the development of atrial fibrillation (AF) early on.14
Simplify Care Pathways
Amvia Sky includes a variety of solutions that streamline workflows throughout the patient journey, from implantation and follow-ups to remote monitoring and outstanding MRI access.
Media
Achieve Physiologic Pacing with LBBAP
Amvia Sky is the first pacemaker approved for left bundle branch area pacing (LBBAP).1 In contrast to conventional RV pacing, this approach allows for physiologic ventricular activation,4 which uses the natural efficiency of the heart’s conduction system. Offering physiologic pacing, Amvia Sky is designed to help you reduce the risk of patients developing pacing-induced cardiomyopathy and its severe consequences.
- LBBAP helps you achieve a more natural myocardial contraction pattern.4
- 95% implant success rates5 with the proven Selectra 3D purpose-built implantation tools to support the LBBAP approach.
Follow Patients’ Physiologic Needs with CLS
Amvia Sky’s unique Closed Loop Stimulation (CLS) sensor technology follows the autonomic nervous system and adapts automatically2 to mimic the natural intrinsic regulation.3 This includes detecting emotional stress, physical stress, or physical activity that does not involve movement.This way, Amvia Sky provides physiologic heart rate adaptation beat-to-beat – ensuring your patients are serviced with the right level of stimulation when needed and contributing to improved quality of life.6,7,8
- Closed Loop Stimulation (CLS) is the only fully physiologic rate response on the market.9
- It measures metabolic demand via impedance changes with every heartbeat – and adapts automatically.
- 7% increase in patient performance during daily activities compared to accelerometers.10
- 45% lower atrial tachyarrhythmia burden as compared to DDDR pacing11
- 69% decrease in risk of AT/AF occurrence.12
- 2 of 3 patients prefer CLS over accelerometer-only pacing.13
Manage Atrial Arrhythmias with aATP
Amvia Sky aims to help patients maintain physiologic heart rates over time. It combines in-office and remote atrial monitoring capabilities with the arrhythmia management tools of Atrial ATP (aATP) to actively address the development of atrial fibrillation (AF) early on.14 Help your patients sustain their sinus rhythm, so that you potentially protect them from progression to symptomatic AF and preserve their quality of life.
- aATP provides multiple automatic therapies in response to detected stable atrial arrhythmia, which may reduce atrial burden, thus helping to avoid atrial remodeling and further buildup of AF.15,16
- BIOTRONIK Home Monitoring® helps you monitor AF burden remotely and detect AF early.14,17
Next-Generation MRI Access with MRI Guard 24/7
Amvia Sky's MRI Guard 24/7 provides an automatic MRI mode switch for easy MRI examinations without pre- and post-scan programming appointments18,19 – streamlined and automated for both care teams and patients.
- Pre- and post-MRI scan programming can take up to 28 minutes,20 which adds waiting time to the patient, the radiology staff and number of personnel needed.20 MRI Guard 24/7 is intended to save some of this time.
- The sensor can be active for complete follow-up intervals up to one year, allowing for MRI scans at any time during this time frame.
Time-Saving Remote Monitoring with BIOTRONIK Home Monitoring®
Amvia Sky helps you deliver exceptional patient-centric care with less effort. It simplifies your patients’ lives,14,21,22 reduces your workload, and can free up time for all care teams involved.
- 97% transmission success21 – BIOTRONIK Home Monitoring’s® fully automatic device pairing allows for an easy “plug-and-go” setup with less patient interaction22 and less need for technical troubleshooting.
- 83% reduction of in-office visits and 50% reduction of follow-up time per patient – potentially freeing up your time to focus on patients in more critical need of medical attention.23
- BIOTRONIK Home Monitoring® demonstrated14,23 potential time and resource savings for care teams and patients alike by safely reducing in-office follow-ups from one to two years. This has also led to the 2021 update of ESC guidelines.
Amvia Sky introduces unique technologies for early remote follow-up before discharge and for quick access to patient data:
EarlyCheck offers early remote follow-up before discharge, supporting efficient workflows and potentially reducing additional waiting time.24
QuickCheck provides fast access to patient data in follow-up situations. Upon clinician’s request in BIOTRONIK Home Monitoring® data typically becomes available within minutes.25
Outstanding Longevity & Industry-Leading Warranty²⁶ ²⁷
Amvia Sky pacemakers offer longevities of more than 15 years.28,29
At the same time, Amvia Sky DR-T/SR-T are backed up by industry-leading warranty programs, offering full warranty of up to 10 years.26,27
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References
1) BIOTRONIK Amvia Sky technical manual, Medtronic Azure XT DR MRI SureScan™ manual; Boston Scientific Accolade MRI™ technical manual; Abbott Assurity MRI™ user’s manual; MicroPort Alizea™ implant manual. 2) Lindovska M, Kameník L, Pollock B, et al. Clinical observations with Closed Loop Stimulation pacemakers in a large patient cohort: the CYLOS routine documentation registry (RECORD). Europace. 2012; 14: 1587–1595. 3) Santini M, Ricci R, Pignalberi C, et al. Effect of autonomic stressors on rate control in pacemakers using ventricular impedance signal. Pacing Clin Electrophysiol. 2004; 27: 24-32. 4) Sharma PS, Patel NR, Ravi V, et al. Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry. Heart Rhythm. 2022; 19(1): 3-11. 5) De Pooter J, Ozpak E, Calle S, et al. Initial experience of left bundle branch area pacing using stylet-driven pacing leads: A multicenter study. J Cardiovasc Electrophysiol. 2022; 33(7): 1540-1549. Disclaimer: This material only summarizes the investigational use of tools for conduction system pacing (CSP) by De Pooter et al. in their clinical study. Please note that the Solia S lead is not approved for CSP. BIOTRONIK CSP tools are not currently approved for conduction system pacing in the United States. Content not intended for US healthcare providers. 6) Menezes AS, Daher MT, Nascente CM, Moreira HG, Moreira TAC, and Campos RN. Correlation among Closed Loop Stimulation, cardiopulmonary capacity, and quality of life PBMR. 2003; 8(2): 119-124. 7) Pavri BB and Russel S. An impedance sensor is superior to an accelerometer for chronotropically incompetent patients with sinus node dysfunction: results of a pilot study with a dual sensor pacemaker. Circulation. 2006; 114: II_749. 8) Coenen M, Malinowski K, Spitzer W, et al. Closed Loop Stimulation and accelerometer based rate adaptation: results of the PROVIDE study, Europace. 2008; 10: 327-333. 9) Malinowski K. Interindividual comparison of different sensor principles for rate adaptive pacing PACE. 1998; 21(PT II): 2209-2213. 10) Abi-Samra FM, Singh N, Rosin BL, DwyerJV, and Miller C. Europace. 2013; 15: 849-856. 11) Puglisi A, Favale S, Scipione P, et al. Overdrive versus conventional closed-loop rate modulation pacing in the prevention of atrial tachyarrhythmias in brady-tachy syndrome: on behalf of the Burden II study group. Pacing Clin Electrophysiol. 2008; 11: 1443-55. 12) Ikeda S, Nogami A, Inoue K, et al. Closed‐loop stimulation as a physiological rate‐modulated pacing approach based on intracardiac impedance to lower the atrial tachyarrhythmia burden in patients with sinus node dysfunction and atrial fibrillation. J Cardiovasc Electrophysiol. 2020; 31: 1187-1194. 13) Coenen M, Malinowski K, Spitz W, et al. Closed loop stimulation and accelerometer-based rate adaptation: results of the PROVIDE study. Europace. 2008; 10: 327-333. 14) Mabo P, Victor F, Bazin P, et al. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012; 33(9): 1105-1111. 15) Nattel S, Burstein B, Dobrev D. Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol. 2008; 1(1): 62-73. 16) Data on file. 17) Varma N, Epstein AE, Irimpen A, 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(4): 325-332. 18) Mullane S, Michaelis K, Henrickson C, et al. Utilization and programming of an automatic MRI recognition feature for cardiac rhythm management devices. Heart Rhythm O2. 2021; 2: 132–137. 19). Data on file. 20) Siddamsetti S, Shinn A, Gautam S. Remote programming of cardiac implantable electronic devices: a novel approach to program cardiac devices for magnetic resonance imaging. J Cardiovasc Electrophysiol. 2022;33(5):1005–1009. 21) Watanabe E, Yamazaki F, Goto T, et al. Remote management of pacemaker patients with biennial in-clinic evaluation: continuous Home Monitoring in the Japanese At-Home study: A randomized clinical trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e007734. doi: 10.1161/CIRCEP.119.007734. 22) Ricci RP, Morichelli L, Quarta L, et al. Long-term patient acceptance of and satisfaction with implanted device remote monitoring, Europace. 2010; 12(5): 674-679. 23) Garcia-Fernández FJ, Asensi JO, Romero R, et al. Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE). Eur Heart J. 2019; 40(23): 1837–1846. 24) Data on file. 25) Data on file. 26) Amvia Sky SR-T 10 years; Limited Warranty for BIOTRONIK Cardiac Implantable Electronic Devices; Medtronic Limited Warranty Summary; Boston Scientific Limited Warranty Information and Forms; Abbott CRM Warranty Procedures Reference Manual; MicroPort Alizea DR™/Alizea SR ™ Implant Manual. 27) Amvia Sky DR-T 8 years; Limited Warranty for BIOTRONIK Cardiac Implantable Electronic Devices; Medtronic Limited Warranty Summary; Boston Scientific Limited Warranty Information and Forms; Abbott CRM Warranty Procedures Reference Manual; MicroPort Alizea DR™/Alizea SR ™ Implant Manual. 28) Amvia Sky SR-T: At 2.5 V/0.4 ms, 60 bpm, 500 Ω; pacing: 50 %, Home Monitoring: OFF, QuickCheck: OFF, RF-Telemetry: OFF. 29) Amvia Sky DR-T: A: 2.5V/0.4ms, 60 bpm, 500 Ohm, pacing: 50%, RV: 2.5V/0.4ms, 60 bpm, 500 Ohm, pacing: 5%, Home Monitoring OFF, QuickCheck: OFF, RF-Telemetry: OFF, Vp Suppression: ON.