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AVEIR™ VR Leadless Pacemaker

AVEIR VR Leadless Pacemaker
Why AVEIR

The next evolution in leadless technology

At Abbott, we adapt quickly to changes in the world around us, harnessing leading-edge science and technology to deliver the best possible solutions for some of the world’s most important health challenges. Medical devices, like the AVEIR VR Leadless Pacemaker (LP), use the most advanced technologies to keep hearts beating more regularly. 

Watch the video below to learn more.

Long-term Retrieval

AVEIR VR LP is designed for long-term retrieval using a dedicated retrieval catheter.2

Long-term Retrieval

 

The AVEIR VR LP's predicate device has an overall long-term retrieval success rate above 88% with helix fixation from up to 9 years of retrieval experience.1,2  Limited data is available for AVEIR VR LP.

Greater than 88%
Projected years of battery life comparison Aveir VR leadless pacemaker vs Micra leadless pacemaker
Download Retrieval Data

Long Lasting

Increased projected battery longevity over other current available leadless pacemakers1, 3 ** opens the door to more patients.

Mean ± SD: 17.6±6.6 years4
95% CI: 16.6 to 18.6 years4

Projected years of battery life comparison Aveir VR leadless pacemaker vs Micra leadless pacemaker

The average battery longevity among Leadless II phase 2 IDE patients at 1 year follow-up is estimated to be 17.6 years.4

48% of the study patients have an estimated battery longevity of over 20 years.

Up to twice the battery capacity
of current VR leadless pacemakers1, 3 *

Aveir VR Leadless Pacemaker battery capacity 243 mAh Micra Leadless Pacemaker 120 mAh

Mapping Prior to Fixation

AVEIR VR LP mapping capability is designed to help reduce the number of repositioning attempts.1,4

120 Clinic Personnel

83.2% of patients had successful implants with no repositioning attempts5

36 Electrophysiologists

96.4% of patients had successful implants in 1 or less repositioning attempts5

Tip electrode anti-rotation suture
display of contact mapping

AVEIR VR LP can measure R-waves, impedance, Current of Injury via commanded EGM, and an initial capture threshold before fixation by simply touching the electrode to the endocardial tissue.1,4 AVEIR VR LP is engaged with a rotational motion into the endocardium. 

Life-changing Innovation

Dual Chamber System Upgradeability

Should new pacing indications present, the software for AVEIR VR Ventricular LP is designed to pair with AVEIR™ AR Atrial LP, allowing the devices to upgrade to an AVEIR™ DR Dual Chamber Leadless Pacemaker System.1**

outline of heart

AVEIR is 1.5T and 3T MR Conditional 

AVEIR VR LP is MR Conditional for full-body scans using a 1.5T or 3T field strength MRI scanner.***

MR triangle

Learn about the AVEIR VR Leadless Pacemaker
implantation and retrieval processes

How it works

View the Clinical Study

See the Data

References

* Battery longevity estimates based on projections derived from published technical specifications and the ISO standard settings
** AVEIR AR Atrial Leadless Pacemaker (LP) and AVEIR DR Dual Chamber Leadless Pacemaker (LP) System are commercially approved for use only in the USA market at this time. AVEIR AR LP and AVEIR DR LP System are currently under review and pending CE mark.
***For additional  specific MR Conditional information, 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

  1. AVEIR™ VR Leadless Pacemaker and Delivery Catheter IFU. ARTEN600175956, ARTEN600175957
  2. Reddy, VY, et al. Worldwide Experience with Leadless Pacemaker Retrievals at 9 years. Presented at 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific Session; Nov 18-20, 2022; Singapore.
  3. Micra‡ VR IFU M991010A001 REV. B.
  4. Reddy VY, Exner D, et al. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC: Clinical Electrophysiology 2023, DOI: 10.1016/j.jacep.2023.01.031.
  5. Reddy, VY et al. Primary Results on Safety and Efficacy from the LEADLESS II-Phase 2 Worldwide Clinical Trial, JACC: Clinical Electrophysiology, 2021, ISSN2405-500X. https://doi.org/10.1016/j.jacep.2021.11.002

Additional References

  1. Sattar et al. Complications of leadless vs conventional (lead) artificial pacemakers - a retrospective review. Journal of Community Hospital Internal Medicine Perspectives Vol. 10,4 328-333. 2 Aug. 2020, doi:10.1080/20009666.2020.178690.
  2. Reddy VY, Cantillon DJ, John IP . San Francisco, CA: 6 May 2016. A comparative study of acute and mid-term complications of leadless vs transvenous pacemakers. Late-Breaking Clinical Trials II. Presented at Heart Rhythm Society 2016; pp. 02–04. Abstract LBCT.
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