March 28th, 2014
Edward J. Schloss reflects on the release of the new Optisure family of ICD leads by St. Jude Medical, as well as the history of leads made by this company.
March 28th, 2013
A case report of a failed St. Jude Medical Durata ICD lead was published yesterday, raising suspicions that this lead may share some of the same potential failure mechanisms of its troubled predecessor, the Riata lead. St. Jude’s ICD lead troubles date back to early case reports involving the Riata and Riata ST leads that ultimately led […]
January 28th, 2013
The researcher and EP who first documented problems with St. Jude next generation leads reacts to the FDA’s recent letter to the company and explains what he is doing for patients who have received these devices.
January 16th, 2013
The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of setbacks and challenges […]
May 10th, 2012
The Heart Rhythm Society meeting kicked off in Boston this morning. Edward Schloss recounts the important opening session in which FDA-recalled St. Jude ICD leads Riata, Riata ST, and Durata were discussed.