* 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
***CAUTION: Dual Chamber configuration is currently investigational and is limited to investigational use only in accordance with Canadian Law. Contact your local sales representative for the regulatory status of the device(s) in Canada
**** 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.
販売名：アヴェイル LP 承認番号：30400BZX00287000
MAT-2213856 v2.0 | Item approved for Japan use only.
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