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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: 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