The problem with St. Jude Medical’s defective Riata and Riata ST leads is well known — lead wires have a potential to poke through insulation and hurt patients. Others have found that the leads fail to provide the defibrillation therapy at high voltages and has killed 22 people.
While doctors discussed best ways to manage the risk of the leads in patients, there was a presentation on whether St. Jude Medical’s highly touted Durata lead should be trusted. Many believe that the Durata lead is similar to the failed Riata and Riata ST leads.
St. Jude Medical has fought this assertion in a bid to insulate the product from a sales decline. It claims that the lead insulation in Durata leads is 50 times more resistant.
The company may have just found an ally in Dr. Charles Love, a respected cardiologist from Ohio, in its effort to distinguish Durata from the Riata.
Dr. Love’s presentation was very positive on the Durata, according to a blog post on the session by Dr. John Mandrola, who described Dr. Love as a friend.
[Dr. Love] showed a number of technical slides to back up his contention that Durata is 85% different from Riata. He liked Durata’s internal design, which brings internal cables closer together. He explained that this decreases shear force. Next, he talked about the positives of Optim insulation. St Jude’s Optim insulation adds significantly to the improvedRiata STdesign changes, is what I took from his message. Comparing it with other “reliable” ICD leads, Dr Love said Durata looked competitive. He quoted Durata’s excellent performance data and noted follow-up on Durata is now available through five years.
I was surprised. It was an overwhelmingly positive assessment of Durata. This is telling coming from Dr Love. He has an excellent reputation and I trust him. When Chuck speaks, I listen.
Another physician — Dr. Edward Schloss, also of Ohio — similarly posted on Dr. Love’s “calming words” regarding Durata, and noted that Love described it as a”very, very different lead.”
[Dr. Love] spent some time going over the design of all St. Jude leads and pointed out the potential benefit of the Optim insulation coating added to Durata and Riata ST Optim leads. Active registries on these newer leads continue to show robust performance approaching 5 years.
All this should be music to the ears of St. Jude Medical, which has been battling the fallout from Riata and worried over the fate of Durata.
[Photo Credit: freedigitalphotos user digitalart]