April 12, 2012 – The gloves are off and the fight has begun between St. Jude Medical and Medtronic over clinical data regarding their implantable cardioverter defibrillator (ICD) leads. St. Jude, the medical device manufacturer of the recently recalled Riata and Riata ST ICD leads, is defending itself this week against a report in the Heart Rhythm Journal, from the Heart Rhythm Society, by Robert Hauser, M.D., FACC, of the Minneapolis Heart Institute (Hauser et al., “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads”). Hauser 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 five out of 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," Hauser said. St. Jude issued a warning letter about the Riata and Riata ST leads to physicians in December 2010. It was thought the leads’ internal conductor wires could abrade and erode through their silicone insulation and “externalize,” causing failures that led St. Jude to voluntarily recall the product from the market. 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 Hauser’s report was obtained from the U.S. Food and Drug Administration (FDA) Manufacturers and User Facility Device Experience (MAUDE) database, 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 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 Hauser. St Jude’s analysis followed the same search criteria as Hauser’s study, but found 74 lead deaths among Riata patients and 377 lead deaths among Quattro Secure patients. For this reason, St. Jude said Hauser’s study included substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead.
“Dr. Hauser’s manuscript is mistaken or misleading in a number of other respects as well,” St. Jude said in a statement. “It is important to note that Dr. Hauser has selectively chosen to include only one Quattro Secure lead model in his analysis versus all of the Riata and Riata ST models for St. Jude Medical. Although we did not include those lead models in our analysis, there are also deaths associated with those additional model numbers.”
St. Jude said the entire premise of the comparison of a recalled silicone-only insulated lead versus Quattro Secure, which is a product insulated with a polyurethane outer insulation, is flawed. The company said it is acknowledged in the industry that silicone-insulated leads are more susceptible to abrasion than leads with newer insulation materials. A more appropriate comparison would have been to compare the Riata and Riata ST leads to other recalled leads. “For example, there are approximately 1,200 MAUDE death reports associated with the recalled Medtronic Sprint Fidelis lead, out of approximately 268,000 leads sold worldwide, or a rate of 447.8 per 100,000,” St. Jude said in its statement. “For Sprint Fidelis leads, note that many cases indicate ‘under litigation’ in the MAUDE report and no detail on the cause of failure is provided. Alternatively, Dr. Hauser could have compared Quattro Secure to St. Jude Medical’s currently available Durata lead, which the company is confident would have resulted in a favorable comparison as well.”
The method of the study itself, using MAUDE reports to compare devices, is not appropriate, St. Jude said. The company points out the home page of the FDA’s MAUDE database states, “MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”
Drawing Medtronic Into the Debate
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. St. Jude posted information on its website from the MAUDE database showing 377 deaths associated with the Medtronic Quattro Secure lead, rather than the 62 that was reported by Hauser.
In addition, in its statement about the issue, St. Jude claimed Medtronic generally reports the least amount of detail compared with other companies in MAUDE database. In addition, the detail and rate of reporting has increased since Medtronic’s Cardiac Rhythm Management business received a warning letter from the FDA in 2009, meaning events prior to this date in the analysis may have been underdetected, St. Jude asserted. An analysis of “lead-related” deaths is biased against manufacturers that more transparently report on device malfunctions, the company concluded.
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 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 percent decline in fourth quarter domestic ICD sales.
GlobalData, a global business intelligence provider, contributed to this story. GlobalData believes that with the negative publicity and the already weak ICD market, St. Jude faces significant challenges ahead.