Wednesday, May 16, 2012

Durata: Questioning the 99%

One of Many St. Jude Ad Trucks Seen at HRS 2012 Scientific Sessions
The boxing match about the safety of St. Jude Medical's newer Durata defibrillator lead reliability continues to spark interest in the EP community.  In one corner is the supporter of the reliability claims made by St. Jude, respected EP and lead explanter Charles Love, MD from Ohio State University Medical Center.  In the opposite corner this morning on Cardiobrief, comes respected ICD-watchdog Robert Hauser, MD:
Cardiobrief:  "Unfortunately, Dr. Greenberg was unable to attend today, but St. Jude’s Dr. Carlson stood bravely in the breach (no pun intended) to describe the performance of St. Jude’s 3500+ Durata leads in its OPTIMUM registry. Follow up was 2.4 years, and my only comment is that 2.4 years in my view is an early experience, not a mid-term experience. The event free survival was >99%. Excluding dislodgments and perforations, which may be operator dependent, there were only 5 lead mechanical problems, namely conductor fractures, in over 8400 implant years. Now this is truly spectacular. There were no inside-out insulation abrasions and no all-cause abrasions. But I have to say, that the Durata leads that I have been looking at in the FDA’s MAUDE database must not have been included in this study."
I'm starting to see the makings of a Tyson/Holyfield match.



Anonymous said...

Really? Driving a truck around with a sign that boasts of freedom from a problem that didn't exist until their own prior generation brought it into our vocabulary? That would be like Toyota trumpeting "zero unintended accelerations" for their new models.

Anonymous said...

I'm 99% sure that your skepticism is 99% warranted.