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™ AR Leadless Pacemaker and AVEIR™ VR Leadless Pacemaker, use the most advanced technologies to keep hearts beating more regularly.
Watch the video below to learn more.
The flexibility to tailor therapy has taken a leap forward. Until now, leadless pacing could only be done in the right ventricle, which meant a conventional pacemaker was the only option for many patients. Now, with the world’s first atrial leadless pacemaker, more patients can benefit from leadless pacing that eliminates the risk of lead- and pocket-related complications and offers no visible scarring or arm movement restriction.
Atrial Pacing for Patients with:
▪ Sinus node dysfunction and normal AV and intraventricular conduction systems
Ventricular Pacing for Patients with:
▪ Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest
▪ Chronic atrial fibrillation
The AVEIR VR LP's predicate device has an overall long-term retrieval success rate above 88% with helix fixation with up to 9 years of retrieval experience.2,3 AVEIR VR LP is designed for long-term retrieval.1 Limited data is available for AVEIR VR LP.
The AVEIR VR LP's predicate device has an overall long-term retrieval success rate of 92.5% for implants ≥ 5 years.3
Increased projected battery longevity over current available leadless pacemakers2,4* opens the door to more patients.
The average battery longevity among Leadless II phase 2 IDE patients at 1 year follow-up is estimated to be 17.6 years
48% of the study patients have an estimated battery longevity of over 20 years.5
* Battery longevity estimates based on projections derived from published technical specifications and the ISO standard settings
**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
1. AVEIR DR FDA Approval
2. Aveir™ VR Leadless Pacemaker and Delivery Catheter IFU. ARTEN600175956
3. 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.
4. Micra‡ VR IFU M991010A001 REV. B
5. 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
a. 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
b. 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.
MAT-2115643 7.0 | Item is approved for U.S. use only