St. Jude Medical ($STJ) is touting the safety and reliability of its Durata leads with Optim insulation in its biannual report on the performance of its cardiac rhythm management devices.
In its report, the company pointed to data showing that Optim insulation reduced the probability of abrasion malfunction in tachycardia leads at 62 months by 91%. "The abrasion resistance of Optim lead insulation has decreased by a factor of 10 the probability of abrasion malfunction in St. Jude Medical's Riata ST Optim and Durata lead families when compared to the Riata and Riata ST lead families," the company added.
"The combined registry data on our Optim leads represent the most robust post-market surveillance monitoring system in the ICD industry, which will also be independently verified by a third-party research institution," Eric Fain, president of the company's cardiac rhythm management division, emphasized in a statement. "We are committed to ensuring that we deliver the highest quality devices possible."
The report comes as the company still wrestles with the fallout from the Riata lead controversy. Last year, the FDA designated St. Jude's Nov. 28 voluntary medical device advisory letter to physicians as a Class I recall, the most serious category. The company acknowledged at the time the leads, which connect implanted defibrillators to the heart, have a higher rate of insulation failures than initially reported. The company stopped selling the product in December 2010.
In its latest report, the company noted that as of Feb. 29, there were 671 confirmed cases of externalized conductors reported on Riata 8F and Riata ST silicone defibrillation leads. The company acknowledges "the passive complaint reporting system results in under-reporting and hence underestimates the true failure rate associated with any given failure mechanism." It also acknowledged that peer-reviewed publications say the incident rate is higher.
One of those who thinks the rate is higher is Dr. Robert Hauser, whose recent study on the leads ignited a firestorm involving the journal HeartRhythm, Medtronic ($MDT) and St. Jude. While St. Jude has questioned his findings favoring Medtronic's Sprint Quattro heart defibrillator lead over its offering, Hauser has defended his research. "It's like we're living in a different universe," he said, as quoted by The Wall Street Journal, when assessing St. Jude's data and that of outside researchers.
But the company is making efforts through registries to help solve safety issues. In fact, it's investing more in them to "understand the performance of the devices and detect early on if there is an issue," Fain said, as quoted by the WSJ. "We understand fully that there's underreporting," he said, a problem registries could help solve.
Currently, St. Jude is evaluating Riata leads in a study of roughly 700 patients from the U.S., Canada, and Japan. It already has enrolled more than 600 patients, and independent doctors are reviewing fluoroscopic images. The company expects to have the initial results on the incidence of externalized conductors before the end of June.
- see the St. Jude release
- download the report here
- see the WSJ report (sub. req.)