Trouble for St. Jude as study flags Durata failures

St. Jude Medical ($STJ) has been working to distance its Durata line of leads from the recalled Riata devices, but a new study reports that some of newer techs suffer from the same problem.

Led by the Minneapolis Heart Institute's Robert Hauser, the study found 52 instances of failing Durata leads in the FDA's adverse events database, including one that resulted in a patient's death, The Wall Street Journal reports.

Most of the failures were the result of the device bumping against other objects in the body--much like the case St. Jude hunted down back in June--Hauser said. But three of the faulty wires were undone by internal insulation failures, similar to the problem that led to St. Jude's costly recall of Riata and Riata ST, devices implicated in at least 20 deaths before their Class I recall.

Even if those three instances are anomalous, the 49 external-abrasion-related failures still raise a red flag, Hauser's study points out. Durata leads use a proprietary coating called Optim, which St. Jude says is 99.9% effective in protecting against external abrasion. But Hauser said the mounting number of failures calls that claim into question and, until more information is available, physicians should stop using the devices.

"I think it is a red flag," he told The New York Times. "I think we need more data. But, fundamentally, I'm afraid that this material is not going to perform as advertised."

For its part, St. Jude told both papers that it is still reviewing Hauser's study but stands by its device.

This isn't the first time the devicemaker and cardiologist have butted heads. Back in April, Hauser published a study finding that Riata leads led to more deaths than Medtronic's ($MDT) Quattro Secure devices. St. Jude fired back, claiming the study had "substantial errors" and unsuccessfully demanding its retraction.

The increased scrutiny of its leads spells more bad news for St. Jude. Last week, the FDA asked the devicemaker to conduct a three-year study of all of its leads, including the recalled Riata and on-the-market Durata. St. Jude is still crawling out from under the Riata debacle, and June's report of a failed Durata lead sent the company's stock into a 6% decline.

- read the study (PDF)
- check out the WSJ's take
- get more from the Times

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