Devices & Diagnostics

Does St. Jude Medical have a Durata problem now?

UPDATE: An earlier version of the story incorrectly reported that the patient with the Durata lead that had externalized conductors died. The FDA Maude adverse event database does show that patients implanted with Durata leads have died but those were not connected to device problems. Externalized conductors is the failure that led to the recall […]

UPDATE: An earlier version of the story incorrectly reported that the patient with the Durata lead that had externalized conductors died. The FDA Maude adverse event database does show that patients implanted with Durata leads have died but those were not connected to device problems. Externalized conductors is the failure that led to the recall of St. Jude Medical older, Riata ICD leads.  

For months, St. Jude Medical (NYSE:STJ) has been assuring cardiologists, patients and its shareholders that the problem of cables poking through its insulation wires was limited to its Riata and older generation of ICD  leads.

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It’s newer Durata lead is far superior to those, the Minnesota device maker has maintained.

But now it appears that the Durata lead, which executives have touted as being 50 times more resistant to lead abrasion than previous models, is showing a chink in its armor.

The Wall Street Journal reported Tuesday that:

According to a report dated April 18 in the U.S. Food and Drug Administration’s Maude database of adverse events, a fluoroscopy of St. Jude’s Durata lead revealed protruding cables, a problem seen in some of the company’s older Riata leads. The event was reported by a physician, and the report wasn’t sent to the manufacturer. It was received by the FDA on May 2.

The article also noted that the Minnesota device maker’s stock swooned 6 percent on the news.

Many believe that aside from the Optim insulation, the Durata is similar in design to the older Riata leads that were hit with a Class I recall by the FDA.

A St. Jude Medical spokeswoman said that as noted in the Maude database filing with the FDA, the adverse event report was not sent to the company, so she couldn’t confirm the details of the specific case.

“We will make every effort to learn more about this report as quickly as possible,” said Rachel Ellington, in an email. “As to your second question, yes, we remain confident in the design of our Durata lead.  To date, there have been no instances of externalized conductors on a Durata lead reported to St. Jude Medical.”