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Safety Alerts
Subset of Medtronic Pacemakers – Potential Circuit Error
On January 17, Medtronic issued an urgent voluntary recall and distribution suspension affecting a subset of dual-chamber pacemakers distributed worldwide between March 10, 2017 and…
January 22, 2019
Safety Alerts
FDA Safety Communication- ZOLL LiveVest 4000
The FDA approved a new software for the ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code 102” is displayed.
January 15, 2019
Safety Alerts
Software Update for LifeVest 4000 Wearable Cardioverter Defibrillator
(Jan 2019 Update) The FDA approved a new software for the ZOLL LifeVest 4000 for patient alerts when a “Call for service – Message Code…
January 15, 2019
Clinical Documents
2019 Appropriate Use Criteria for Multimodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease
This document is the second of two companion appropriate use criteria (AUC) documents developed by the American College of Cardiology, American Association for Thoracic Surgery,…
January 2, 2019
Clinical Documents
Pediatric and Congenital Electrophysiology Society Initiative on Device Needs in Pediatric Electrophysiology
In the past 5 years, there have been several initiatives in pediatric cardiology, specifically in the heart failure and interventional cardiology domains, to develop and…
December 20, 2018
Clinical Documents
Harmonized Outcome Measures for Use in Atrial Fibrillation Patient Registries and Clinical Practice
The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in atrial fibrillation (AF) patient registries…
November 15, 2018
Clinical Documents
2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delay
The purpose of this guideline, accompanied by the Executive Summary and the Systematic Review, is to provide guidance to clinicians for the management of patients with bradycardia or…
November 6, 2018
Safety Alerts
Safety Advisory: Boston Scientific First Generation S-ICD System SQ-RX™ Model 1010 Pulse Generators (PG)
Boston Scientific released a product advisory related to accelerated battery depletion and a shortened replacement interval observed in some of the first generation Subcutaneous Implantable…
November 5, 2018
Clinical Documents
2018 AHA/ACC Guideline for the Management of Adults with Congenital Heart Disease
The 2018 adult congenital heart disease (ACHD) guideline is a full revision of the 2008 ACC/AHA Guidelines for the Management of Adults with Congenital Heart Disease,…
July 16, 2018
Comment Letter
2019 MPFS Rule – Comments
December 21, 2018