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Amvia Sky HF-T QP / HF-T
With a 30% non-response rate to CRT1 , therapy optimization is essential for clinicians taking care of CRT patients. From the implantation to managing individual patients, accommodating each condition and need is both demanding and time-consuming for healthcare teams.
Amvia Sky CRT-P offers a complete set of options to address your and your patients’ needs – designed to enhance CRT response. From the largest choice of LV pacing polarities2 to unique rate and CRT adaptation features, Amvia Sky CRT-P offers an automatic and simple-to -use3 way to optimize patient response. Amvia Sky is the first CRT-Pacemaker approved for left bundle branch area pacing (LBBAP)2, providing an alternative method to deliver physiologic therapy to your heart failure patients. At the same time, Amvia Sky CRT-P automates and streamlines routine tasks during implantation, in-office follow-ups, remote monitoring, and MRI workflows.
By simplifying and automating time-intensive workflows, Amvia Sky CRT-P can help you save time4 – so you can focus on other clinically relevant tasks, while offering your patients the potential of improved care and greater quality of life.
Product Highlights
Achieve Physiologic Pacing
Amvia Sky is the first CRT-Pacemaker approved for left bundle branch area pacing (LBBAP)2, providing an alternative method to deliver physiologic therapy to your heart failure patients
Personalize Therapy
Amvia Sky CRT-P reduces the effort required4 by offering a comprehensive set of automatic options to individualize physiologic treatment according to each patient’s needs
Streamline Care Pathways
Amvia Sky CRT-P offers unique automatic and remote technologies for your heart failure patients, potentially streamlining time-consuming workflows along the entire patient care pathway: from implantation and follow-ups to remote monitoring and outstanding MRI access
Open Achieve Physiologic Pacing with LBBAP configuration options Achieve Physiologic Pacing with LBBAP
Amvia Sky is the World’s First CRT-Pacemaker Approved for Left Bundle Branch Area Pacing (LBBAP).2 LBBAP can be beneficial to deliver resynchronization therapy in patients for whom conventional CRT is not possible5 or unlikely to be effective, allowing for physiologic ventricular activation along the natural pathways, faster than with conventional CRT.6,7
- 95% implant success rates8 with the proven Selectra 3D purpose-built implantation tools to support the LBBAP approach.
Unique Rate Adaptation with CLS
Amvia Sky CRT-P's Closed Loop Stimulation (CLS) sensor technology follows the autonomic nervous system and adapts automatically9 to mimic the natural intrinsic regulation,10 which can be beneficial to CRT patients.11
- CLS measures the metabolic demand via impedance changes with every heartbeat – and adapts automatically.
- The only fully physiological rate response on the market.12
- In contrast to accelerometers, CLS is designed to detect emotional stress, physical stress, or physical activity that does not involve movement.
Industry-Leading Choice of LV Pacing Polarities²
Amvia Sky CRT-P offers 20 LV pacing polarities, giving you more options to select the most responsive one - including options for basal pacing, Phrenic Nerve Stimulation (PNS) management and electronic repositioning.
Fast and Easy Vector Selection with Auto LV VectorOpt
Amvia Sky CRT-P's Auto LV VectorOpt provides the optimal vector choice across 20 vectors in less than 2.5 minutes.13
- Auto LV VectorOpt provides automatic threshold measurements with fast and easy access to parameters that indicate the optimal choice.
- Saving you the effort to do it yourself and potentially speeding up procedure time.
Continuous CRT Optimization with CRT AutoAdapt
Amvia Sky CRT-P features CRT AutoAdapt:
- Every minute,14 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 optiomization with focus on clinically relevant intrinsic timing.
- Automatic selection of paced chambers based on A-RV and A-LV conduction patterns.
- Saves battery life with up to 12 years, 1 month in LV-only pacing.15
Manage Atrial Arrhythmias with aATP
Amvia Sky CRT-P's Atrial ATP (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.16,17
- BIOTRONIK Home Monitoring helps you monitor AF burden remotely and detect AF early.18,19
Next-Generation MRI Access with MRI Guard 24/7
Amvia Sky CRT-P's MRI Guard 24/7 provides an automatic MRI mode switch for easy MRI examinations without pre- and post-scan programming appointments20.21 – streamlined and automated for both care teams and patients.
- Pre- and post-MRI scan programming can take up to 28 minutes,22 which adds waiting time to the patient, the radiology staff and number of personnel needed.22 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®
Proven BIOTRONIK Home Monitoring® system offers automatic, daily transmission and verification.
- No patient involvement is required.23
Open configuration options
- 97% transmission success24-BIOTRONIK Home Monitoring’s fully automatic device pairing allows for an easy “plug-and-go” setup with less patient interaction23 and less need for technical troubleshooting.
Amvia Sky CRT-P 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.25
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.26
Outstanding Longevity & Industry-Leading Warranty²⁸
Amvia Sky CRT pacemakers offer longevities of more than 12 years.27
At the same time, Amvia Sky HF-T QP/HF-T are backed up by industry-leading warranty programs28, offering full warranty of 6 years.
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References
1) Naqvi SY, Jawaid A, Goldenberg I, and Kutyifa V. Non-response to Cardiac Resynchronization Therapy. Curr Heart Fail Rep. 2018; 15: 315-321. 2) BIOTRONIK Amvia HF-T QP technical manual, Medtronic Percepta Quad CRT-P MRI SureScan™ manual; Boston Scientific Visionist X4™ technical manual; Abbott Allure Quadra MP RF™ user’s manual; MicroPort REPLY CRT-P™ implant manual. 3) Data on file. 4) Data on file. 4) Data on file. 5) Vijayaraman P, Herweg B, Verma A, et al. Rescue left bundle branch area pacing in coronary venous lead failure or nonresponse to biventricular pacing: Results from International LBBAP Collaborative Study Group. Heart Rhythm. 2022; 19(8): 1272-1280. 6) Li X, Qiu C, Xie R, et al. Left bundle branch area pacing delivery of cardiac resynchronization therapy and comparison with biventricular pacing. ESC Heart Fail. 2020; 7(4): 1711–1722. 7) Wang Y, Gu K, Qian Z, et al. The efficacy of left bundle branch area pacing compared with biventricular pacing in patients with heart failure: A matched case-control study. J Cardiovasc Electrophysiol. 2020; 31(8): 2068–2077. 8) 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. 9) 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. 10) 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. 11) Proff J, Merkely B, Papp Ret al. Impact of closed loop stimulation on prognostic cardiopulmonary variables in patients with chronic heart failure and severe chronotropic incompetence: a pilot, randomized, crossover study Europace (2021) 23, 1777–1786. 12) Malinowski K. Interindividual comparison of different sensor principles for rate adaptive pacing PACE. 1998; 21(PT II): 2209-2213. 13) Data on file. 14) BIOTRONIK Amvia Sky Technical Manual. 15) A/R/LV: 2.5 V/0.4 ms. 60 bpm, 500 Ω; A: pacing: 10%; RV: pacing: 50%, LV: pacing: 100%; Home Monitoring: OFF, QuickCheck: OFF; RF telemetry: OFF; CRT AutoAdapt: ON. 16) Nattel S, Burstein B, Dobrev D. Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol. 2008; 1(1): 62-73. 17) Data on file. 18) 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. 19) 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. 20) Data on file. 21) 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. 22) 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. 23) 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. 24) 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; 13(5): e007734. doi: 10.1161/CIRCEP.119.007734. 25) Data on file. 26) Data on file. 27) A/R/LV: 2.5 V/0.4 ms. 60 bpm, 500 Ω; A: pacing: 10%; RV: pacing: 50%, LV: pacing: 100%; Home Monitoring: OFF, QuickCheck: OFF; RF telemetry: OFF; CRT AutoAdapt: ON. 28) 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 REPLY CRT-P™ implant manual.