FDA demands 3-year study of St. Jude's leads

Despite a 2011 recall, St. Jude Medical's ($STJ) Riata leads are still implanted in about 79,000 patients, and the FDA is tasking the devicemaker to conduct three-year postmarket surveillance studies on the recalled techs and their next-gen replacements.

For Riata and Riata ST leads, the agency wants to know the number of patients with faulty implants, how long it took the leads to malfunction and what adverse effects the patients experienced. The FDA is also asking St. Jude to study its QuickSite and QuickFlex leads--recalled in April over abrasion risks--and the on-the-market Durata devices.

And the bad PR doesn't stop there. The agency is advising physicians to X-ray all patients with Riata implants, warning that the insulation erosion cited in the recall could lead to serious injury or death.

The majority of St. Jude's leads function just fine, FDA device chief Dr.  Jeffrey Shuren said in a statement, but the risks warrant a closer look. "[T]he agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore, the postmarket surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions," Shuren said. 

While the Durata line of products hasn't suffered a recall, the blanket scrutiny on St. Jude's leads will likely stick in the minds of doctors and affect future sales, one analyst told The Washington Post. Accordingly, St. Jude's shares dropped 4% late Thursday following the agency's announcement.

The task for St. Jude is to distance Durata from the alarm over Riata, and the company has continuously said that the problems with the silicone-coated recalled leads don't affect the new models, which are insulated with polyurethane. Back in June, when a report of Durata abrasion went public, St. Jude pounced on the issue, investigating the device in question and determining that the problem was caused by external abrasion, not internal erosion.

- read the FDA's statement
- get more from the Post

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