FDA Orders Expanded Surveillance of St. Jude Leads


The Food and Drug Administration is requiring St. Jude Medical Inc. to augment its postmarket surveillance efforts for its implantable cardioverter defibrillator leads, including its currently marketed Durata lead, based on concerns about insulation failure.

The agency announced Section 522 postmarket surveillance orders on Aug. 16, requiring 3-year studies of the firm’s Riata and Riata ST ICD leads, which were removed from the market in 2010 based on the potential for the device’s conducting material to breach its silicone insulation as a result of so-called inside-out abrasion.

In addition, the Section 522 order requests expanded data collection for St. Jude’s QuickFlex LV and QuickSite LV cardiac resynchronization therapy silicone-insulated leads, which were removed from the market earlier this year for the same reasons.

Most notably, perhaps, the order also addresses the firm’s Durata lead, which employs a different Optim insulation. No cases of inside-out abrasion have been confirmed for the newer leads, but St. Jude has been fighting off perceptions in the electrophysiology community that Durata could experience similar issues. FDA now says it wants to track additional performance details on the marketed lead.

In particular, "The current postapproval study for Durata does not address concerns related to insulation failure," said Sarah Lynn-Clark, an FDA spokeswoman.

"The FDA included Durata in the postmarket surveillance study order to proactively obtain additional, detailed performance information, which clinicians will be able to utilize in individual care plans for their patients, and which the FDA will utilize as part of our mission to protect and promote the public health," she explained.

The Section 522 studies for the Riata and Riata ST leads, meanwhile, must address four main points, according to FDA: the number of patients with evidence of insulation failure and whether the failure was detectable with X-ray imaging; how soon after implantation the lead insulation fails; the time between lead implantation and lead malfunction; and adverse events associated with treatment for failing or malfunctioning leads.

St. Jude in Talks With FDA

St. Jude is already conducting multiple postmarket studies for both the Riata and Durata leads.

The company has three patient registry studies ongoing for Durata, tracking data from about 10,000 implanted leads. St. Jude recently decided to hand over the raw data from the registries to academics for an independent analysis as part its effort to distinguish the performance of Durata from Riata.

St. Jude is also conducting a 2-year study, including patient imaging assessment, of 724 patients implanted with Riata leads.

The company says it is in discussions with FDA about the extent to which its current studies may satisfy the new orders.

"There may be additional data to be collected, but we are still working with the FDA to understand whether additional studies need to be initiated," said Amy Jo Meyer, a spokeswoman for St. Jude.

"We support post-market lead surveillance programs, and currently have the largest postmarket lead surveillance registries in the industry," Ms. Meyer stressed.

Imaging of Implant Patients Also Recommended

Beyond the postmarket surveillance orders, FDA also formally recommended yesterday that all patients who have Riata and Riata ST leads undergo x-ray or other imaging tests as a check for insulation abnormalities. But the agency cautioned against routine removal of leads without careful examination of the benefits and risks to an individual patient.

Both FDA and St. Jude stress that even in cases of externalized conductors, the majority of Riata and Riata ST leads continue to function normally.

This story appears courtesy of "The Gray Sheet," a weekly Elsevier publication covering the medical device and diagnostic industries. To learn more, contact customer care at 800-332-2181 or sign up for a free trial.

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