The software for Aveir VR Leadless Pacemaker was designed for expandability to a dual chamber system to be introduced to the Aveir VR system via software updates in the future, upon regulatory approval.1***
AVEIR IS 1.5T AND 3T MR CONDITIONAL
Aveir is MR Conditional for full body scans using a 1.5T or 3T field strength MRI scanner.****
* Limited data is available for Aveir Leadless Pacemaker. The Aveir Leadless Pacemaker’s predicate device has chronic retrieval success rate >80% with helix fixation through 7 years regardless of implant duration
** ISO standard settings: VVIR, 60bpm, 2.5V @0.4 ms, 600 Ω, 100% pacing
*** The LP device electronics are designed to be enabled by future software, upon regulatory approval, to support dual chamber pacing in the future. Dual chamber pacing system is currently in clinical trial (ClinicalTrials.gov NCT #05252702) and limited to investigational use only
**** Stability of pacing capture thresholds is required prior to MRI scan. For additional information about specific MR Conditional, including warnings, precautions, adverse conditions to MRI scanning and potential adverse events, please refer to the MRI-Ready Leadless Systems Manual at medical.abbott/manuals or check our MRI Ready resources at cardiovascular.abbott/mriready
Aveir™ VR Leadless Pacemaker and Delivery Catheter IFU. ARTEN600175956
Reddy VY, et al. Chronic Retrievability with a Leadless Pacemaker: A Worldwide Nanostim Experience out of 7y. Presented at: HRS 2021; Jul 28-31, 2021; Boston, MA.
Micra‡ VR IFU M991010A001 REV. B
Reddy, VY et al. Primary Results on Safety and Efficacy from the LEADLESS II-Phase 2 Worldwide Clinical Trial, JACC: Clinical Electrophysiology, 2021, ISSN 2405-500X, https://doi.org/10.1016/j.jacep.2021.11.002.
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MAT-2112095 v4.0 | Item is approved for U.S. use only
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