Leadless Pacemakers

Traditional pacemakers have been the standard treatment option for patients with severe/symptomatic bradycardia, an arrhythmia indicating an unusually slow heart rate.  While there have been significant advancements in pacemaker technology since its introduction in 1958, pacemaker devices have continued to require the creation of a surgical pocket under the skin on the upper portion of the chest wall in order to hold the power source, and the use of leads to reach the pacing site.  Current leadless pacemaker devices are self-contained enclosed capsules that include the pacemaker electronics and battery, and are delivered via catheter to the right ventricle of the heart.  Leadless pacemakers function similarly to traditional single-chamber ventricular pacemakers without requiring transvenous leads or the need for a surgical pocket.      

CMS issued a Medicare National Coverage Determination (NCD) on January 18, 2017 which allows for coverage of leadless pacemakers under Coverage with Evidence Development (CED) with certain conditions. The complete determination is available on our website.

Decision Memo

Clinical Study Approvals

Study Title:  Aveir AR Coverage With Evidence Development (CED) Study (ARRIVE)
Sponsor:  Abbott Medical Devices
Clinicaltrials.gov number:  NCT06100770
CMS Approval Date: 01/18/2024

Study Title:  Aveir DR Coverage With Evidence Development (CED) Study
Sponsor:  Abbott Medical Devices
Clinicaltrials.gov number:  NCT05932602
CMS Approval Date: 10/31/2023

Study Title:  Aveir VR Coverage With Evidence Development Post-Approval Study
Sponsor:  Abbott Medical Devices
Clinicaltrials.gov number:  NCT05336877
CMS Approval Date: 06/21/2022

Study Title:  Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
Sponsor:  Boston Scientific
Clinicaltrials.gov number: NCT04798768
Investigational Device Exemption (IDE) Number: G200319
CMS Approval Date: 01/20/2022

Study Title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Sponsor: Abbott Medical Devices
ClinicalTrials.gov Number: NCT04559945
CMS Approval Date: 3/16/2021

Study Title: Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
Sponsor: Medtronic
ClinicalTrials.gov Number: NCT04235491
CMS Approval Date: 2/5/2020

Study Title: The Micra CED Study
Sponsor: Medtronic, Inc
ClinicalTrials.gov Number: NCT03039712
CMS Approval Date: 03/09/2017

Study Title: Micra Transcatheter Pacing System Post-Approval Registry
Sponsor: Medtronic, Inc
ClinicalTrials.gov Number: NCT02536118
PMA Number: P150033
CMS Approval Date: 02/09/2017