St. Jude Medical Inc. (STJ) has been told by U.S. regulators to conduct imaging studies on its Durata leads, wires that connect life-saving defibrillators to the heart, to ensure the safety of the devices.
St. Jude has post-marketing studies under way for Durata, a new version of the Riata leads the company stopped selling in 2010 and recalled last year because the wires can break out of their insulation. The Food and Drug Administration is now asking for imaging tests on about 500 patients with Durata leads to see whether there are early signs of failure with the insulation, according to a letter from the agency to the St. Paul, Minnesota-based company obtained by Bloomberg News.
Defibrillators and the leads used to connect them to the heart made up almost one-third of St. Jude’s $5.6 billion in 2011 sales. The market has been contracting for the past several years on concern about safety and overuse of the devices.
“That the FDA is requiring an additional study of Durata, despite St. Jude’s current and extensive registry data, again shows the FDA’s level of unease with the situation,” said Raj Denhoy, an analyst at Jefferies & Co. in New York, in a note to clients. “Despite the continued presentation by St. Jude of their internal data showing the Durata is safe, the FDA remains unconvinced. Moreover it is sure to raise questions in clinicians who chose to continue to implant Durata.”
The agency is concerned about insulation breaches, known as externalization, as well as abrasions under the shock coil that can lead to electrical malfunction and death, according to the FDA’s letter. The studies, which should follow patients for at least three years, will help determine whether Durata is showing signs of the failures that led the company to pull Riata off the market before symptoms developed in patients.
Imaging studies “should be conducted for every patient at enrollment and every six months through three years after the initial evaluation or until evidence of lead compromise,” the agency said in its letter.
St. Jude is reviewing the FDA’s request and comparing it with information already being gathered in a Durata registry, Amy Jo Meyer, a company spokeswoman, said in a telephone interview. The analysis will determine what additional data the company will collect or whether new studies are needed, she said.
The agency yesterday said that all patients with Riata leads should get X-rays or other imaging tests to detect potential defects. Although they haven’t been sold in the U.S. for more than 18 months, about 79,000 of the wires are still implanted in American patients, according to the company.
Similar imaging studies involving about 500 patients should also be conducted on Riata and on two older leads, the QuickSite and QuickFlex, that St. Jude stopped selling in April after reports of wires protruding from the insulation.
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