Implantable Cardioverter Defibrillator (ICD)

This channel includes news and new technology innovations for implantable cardioverter defibrillators (ICD) used to treat tachycardia arrhythmias and heart failure. This includes cardiac resynchronization therapy defibrillators (CRT-D).

The Unify ICD is one of the SJM devices in an FDA warning letter
Feature | Implantable Cardioverter Defibrillator (ICD) | April 14, 2017 | Dave Fornell
April 14, 2017 — The U.S. Food and Drug Administration (FDA) sent a warning letter to Abbott/St. Jude Medical (SJM)...
An electrophysiology EP ablation procedure to treat a heart arrhythmia
Feature | HRS | May 16, 2017
May 16, 2017 — Here is a list of the late-breaking clinical trials presented at the Heart Rhythm Society (HRS) 2017...
Biotronik Launches New ICD Lead With Helical Design in Europe
News | Leads Implantable Devices | April 12, 2017
April 12, 2017 — Biotronik announced the European launch of a new lead for tachycardia therapy that features a helical...
Videos | EP Lab | April 10, 2017
A discussion with Heart Rhythm Society (HRS) President Michael Gold, M.D., Ph.D., director of cardiology and associate...
Biotronik, ProMRI Configurator tool, MR-conditional cardiac devices, ProMRI SystemCheck
Technology | Implantable Cardiac Monitor (ICM) | February 14, 2017
February 14, 2017 — Biotronik has developed an online tool that streamlines the workflow for physicians selecting the...
NCDR, ACC, JACC, American College of Cardiology, national trends, heart disease treatments, trends in cardiovascular care
News | Cath Lab | January 23, 2017
January 23, 2017 — Over 93 percent of heart attack patients are receiving stents within the guideline-recommended...
ICDs, non-ischemic cardiomyopathy, University of Alabama at Birmingham study, Circulation
News | Implantable Cardioverter Defibrillator (ICD) | January 18, 2017
January 18, 2017 — A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause...
ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillator (ICD) | January 17, 2017
January 17, 2017 — Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving...
The FDA confirmed the cybersecurity vulnerabilities of St. Jude ICDs, pacemakes, implantable cardioverter defibrillators, CRT and other EP devices with wireless connections.
Feature | EP Lab | January 09, 2017 | Dave Fornell
January 9, 2017 — The U.S. Food and Drug Administration (FDA) issued a safety communication today concerning patient...
The FDA wants to regulate cybersecurity of ICDs and other medical devices.

The FDA has concerns about the cybersecurity of implantable medical devices with wireless connections for patient monitoring or adjustments to how the device functions. Changing the function of an implantable cardioverter defibrillator (ICD) using wireless access to the device could present a major patient safety issue.

News | Cybersecurity | December 29, 2016 | Dave Fornell
As wearable and implantable patient monitoring or therapy devices become more sophisticated with advanced wireless...
Medtronic, Claria MRI Quad CRT-D SureScan, FDA approval
Technology | Cardiac Resynchronization Therapy Devices (CRT) | November 15, 2016
November 15, 2016 — Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI ...
SJM, st. Jude Medical, FDA recall, Battery depletion, Recalls ICDs and CRT-D
Feature | Implantable Cardioverter Defibrillator (ICD) | October 25, 2016 | Dave Fornell
October 25, 2016 — St. Jude Medical is recalling 251,346 of its Fortify, Unify and Assura implantable cardioverter...
Medtronic, FDA approval, MRI, MR-conditional scanning, cardiac devices
Technology | EP Lab | October 13, 2016
October 13, 2016 — Medtronic plc is the first company to receive U.S. Food and Drug Administration (FDA) approval for...
EP device cyber security, SJM, St. Jude Medical
News | EP Lab | September 07, 2016
September 7, 2016 — St. Jude Medical Inc. (SJM) has filed a lawsuit against Muddy Waters Consulting LLC, Muddy Waters...
Cybersecurity concerns were raised over the St. Jude Medical (SJM) Merlin@home EP device home monitoring system

St. Jude Medical said recent claims of the cyber attack vulnerability of its [email protected] remote monitoring system and its implantable EP devices are not true.

Feature | EP Lab | August 29, 2016 | Dave Fornell
August 29, 2016 — Investment research firm Muddy Waters Capital released a report Aug. 25 saying it believes St. Jude...