Although St. Jude Medical, Inc. (“SJM”) recalled its Riata defibrillator leads last year because of faulty silicone covering of the unit’s metal wiring, approximately 79,000 U.S. patients still have the Riata defibrillator unit implanted. Frighteningly, a multicenter study released last Thursday concluded that the Riata defibrillator leads performed “significantly worse” than Medtronic Inc.’s Quattro leads.
The study, which was funded by the Minneapolis Hearth Institute Foundation and Abbot Northwestern Foundation, was presented at the Heart Rhythm Society meeting in Boston, Massachusetts. The seven participant centers retrospectively collected data and “evaluated the leads for all causes of failure, including cases where cables wore through their coating and electrical malfunctions.” Their findings suggest that Riata ST leads performed significant worse than Quattro leads. Additionally, nearly a third of all leads with exposed cables malfunctioned.
Ironically, the study’s data are in keeping with Dr. Hauser’s recent conclusions as described in my March 28, 2012 blog titled Study Links St. Jude Heart Wires to 22 Deaths. As followed-up in my April 6, 2012 blog, St. Jude Medical Seeks Retraction of Hearth Rhythm Journal Manuscript, Dr. Hauser’s credibility and methods at arriving at those conclusions were later discredited by SJM, who sought a retraction of the study.
With this latest study in support of Dr. Hauser’s general hypothesis, SJM faces heightened concerns about its new line of leads, the Durata.
Source: Dow Jones Newswires & FoxBusiness.com