Looks like the Food and Drug Administration is not buying St. Jude Medical’s (NYSE:STJ) insistence that the Durata ICD lead is safe.
While some have argued that the Durata leads are very similar in design to the recalled Riata and Riata ST defibrillator leads and will fail too, St. Jude has long fought the notion arguing instead that the design differences are significant. It has stressed that the the Durata comes coated with its proprietary Optim technology that is 50 times more resistant to abrasion which the recalled Riata leads did not have.
But on Thursday, the FDA issued a press release, noting among other things that it is requiring St. Jude Medical to do a post-marketing surveillance study of the Durata leads.
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The safety of Durata is a sensitive topic. Some cardiologists have publicly given it a thumbs up, but others are afraid to implant patients with it. They worry that wires will poke through their insulation just as the Riata family of leads are prone to do. And investors are also paying attention – a single report of an externalized conductor led investors to dump the stock in June. Later St. Jude Medical proved that their fears were misplaced.
On Thursday, in addition to requiring St. Jude to monitor Durata, the agency asked the the Minnesota device maker to do similar studies for four recalled leads – Riata, Riata ST, QuickFlex LV CRT leads and QuickSite LV CRT leads.
The Riata and Riata ST were recalled in November, 2011 for the potential of lead externalisation. The QuickSite and the QuickFlex LV VRT leads were recalled in April for lead abrasion.
The agency recommended that patients implanted with the Riata and Riata ST ICD leads needed to monitor the health of the lead insulation by taking routine X-rays or other alternative imaging methods. However, the FDA cautioned against removal of the leads without weighing the risks and benefits to a patient.
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““The majority of Riata and Riata ST leads, including those that show signs of electrical conductor migration or externalization, continue to function normally and provide life-saving support for patients,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health, in a news release. “However, the 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.”
A St. Jude Medical spokeswoman wrote via email that “the overall accumulation of data continues to support the safety and reliability of our Durata leads.”
In addition, Amy Jo Meyer issued a lengthy statement, a portion of which is below:
We understand the FDA’s decision to recommend fluoroscopic or x-ray screening of all patients with a Riata lead, in order to establish a baseline of understanding about the incidence rate of externalized conductors. St. Jude Medical previously announced we have completed the first phase of a multicenter, prospective study of the incidence rates of externalized conductors and reported on the results last month. Our study will continue to evaluate the performance of Riata leads – both with and without externalized conductors – over a minimum of the next two years to determine how they function over time, which may help further inform patient management considerations.
We support post-market lead surveillance programs, and currently have the largest post-market lead surveillance registries in the industry. We will continue to collaborate with the FDA to understand the ongoing performance of our leads and the initiation of any additional studies.
Meanwhile Dr. Robert Hauser, a prominent cardiologist with the Minneapolis Heart Institute is working on a report on St. Jude Medica’s highly-touted Optim technology. St. Jude Medical and Dr. Hauser are not exactly bosom buddies.
