LONDON, UK (GlobalData), 11 April 2012 - The gloves are off and the fight has begun. St. Jude, the medical device manufacturer of the recently recalled Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads must defend its honor against a report by Dr. Robert Hauser of the Minneapolis Heart Institute. Dr. Hauser’s report compared 71 deaths associated with St. Jude’s Riata and 62 associated with Medtronic’s Quattro Secure, a competing product. Of the Riata deaths, 22 out of 71 were identified as resulting from lead failure as compared to 5 out 62 Quattro Secure deaths. The study suggests that unlike the Medtronic leads, the St. Jude Riata lead deaths were caused by electrical malfunction at high voltages. This differs from the previous conclusion that externalized cables (lead wires coming out of their insulation) were the culprit.
“While investigators have focused on externalized cables, our study suggests that the greater risk to patients is the loss of the insulating barrier between high-voltage components, particularly between an abraded high-voltage defibrillator cable and the shocking coil or pulse-generator can,” Dr. Hauser said. St. Jude issued a warning letter about the Riata and Riata ST leads to physicians back in December 2010. It was thought the leads’ internal conductor wires could abrade and erode through their silicone insulation and “externalize”, causing failures which led St. Jude to voluntarily pull the product from the market. This was a prudent decision, as the FDA later followed with a class I recall a year later. The study concludes that St. Jude’s leads were “prone to high-voltage failure”, which in many cases was related to electrical shorting rather than externalization.
The data for Dr. Hauser’s report was obtained from the Manufacturer and User Facility Device Experience database (MAUDE), which includes information from companies and doctors about complications that arise in patients with medical devices. The findings of the study have since been published in the peer-reviewed Heart Rhythm Society’s journal and have really heated things up between St. Jude and Dr. Hauser. Last week, St. Jude called for a retraction of the report, alleging that it contains “inaccurate facts” and “biased analysis.” The Heart Rhythm Society, however, stated that it does not plan to retract the article.
St. Jude has questioned the very data from MAUDE which Dr. Hauser used in his analysis, stating that they have been unable to reproduce his results. Since the report was published, St. Jude claims to have spent hundreds of hours trying to reach the same conclusions as Dr. Hauser. St Jude’s analysis followed the same search criteria as Dr. Hauser’s study, but found 74 lead deaths among Riata patients and 377 lead deaths among Quattro Secure patients.
St. Jude claims that the original report undercounted the number of deaths tied to Medtronic’s Quattro Secure ICD leads, drawing Medtronic into the fray. Over the weekend, St. Jude CEO Daniel Starks further ratcheted up the tension by accusing Medtronic of leading a “whisper campaign” with the hope of gaining market share in the cardiac rhythm management market from St. Jude’s struggles. “We have competitors going to physicians and informing them, either incompletely or mistakenly, of a competitively hostile view of the facts”, Starks said.
Medtronic fired back with its own analysis of the MAUDE data, which supports Dr. Hauser’s study. “This is not a new accusation. From the very beginning of this Riata issue, St. Jude has been making claims that this is nothing more than a marketing campaign by Medtronic,” Medtronic spokesman Chris Garland said. “Medtronic has reviewed the MAUDE filings, applying the search criteria that Dr. Hauser used in his paper. Our results are roughly in line with Dr. Hauser’s results.”
The battle continues, and at stake is the hefty prize of the $4.3 billion ICD market. St. Jude has already seen declining sales, reporting a 13% decline in fourth quarter domestic ICD sales. GlobalData believes that with the negative publicity and the already weak ICD market, St. Jude faces significant challenges ahead.
*St. Jude and Medtronic at Battle Over ICD Leads; Dr. Hauser Holds the Heart of the Matter
This expert insight was written by GlobalData’s head analyst for medical devices, Derek Archila. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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