UPDATE: Scroll down to see St. Jude Medical’s detailed statement.
Hauser, a prominent cardiologist from Minneapolis Heart Institute known for studying how heart devices function, has concluded that St. Jude Medical’s (NYSE:STJ) highly touted Durata lead is not as immune to lead abrasion as the Minnesota medical device maker would have people believe.
St. Jude Medical has long said that a unique silicone and polyurethane copolymer called Optim – and licensed from a subsidiary of AorTech International – that coats its newer leads including Durata and Riata ST Optim is 50 times more resistant to lead abrasion.
But a new study that Hauser and co-authors conducted found that Optim did not prevent lead abrasions, whichdeveloped less than four years after implant. The study was based on St. Jude Medical’s own analysis of returned leads that are contained in the MAUDE (Manufacturer and User Experience) database. The study entitled “Failure of a novel silicone-polyurethane copolymer (Optim) to prevent implantable cardioverter-defibrillator lead insulation abrasions” was published in the Europace journal. The study recommends that the Durata and Riata ST Optim leads need to be studied further.
In an interview Tuesday, Hauser said that he generally believes that if there is a question about a lead, then it is best not to use it, particularly when there is choice in the marketplace.
“I can’t say that Durata is a bad lead but I am not sure it’s a good one,” Hauser said. “Medtronic, Boston Scientific have leads with a good track record. I haven’t studied the Biotronik lead.”
Hauser added that the Food and Drug Administration’s dictum ordering St. Jude Medical to conduct a three-year post marketing surveillance of the Durata lead is a “very good idea.”
In response, a St. Jude Medical spokeswoman said that the company is reviewing Hauser’s study.
“We welcome ongoing discussion and research about the performance of our products, and believe it is important to consider all of the available information to understand the clinical performance of a device. To date, the accumulation of data continues to support the overall safety and reliability of our Durata leads,” said Amy Jo Meyer, in an email.
It remains to be seen whether St. Jude will try once again to take public aim at Hauser. The last time he published a study on St. Jude’s recalled Riata and Riata ST leads, the companydemanded a retraction and tried to discredit him, something that many felt was unprecedented.
When asked about that, Hauser said he didn’t care if he were targeted.
“You mean to say they don’t love me? ” he joked, adding that the company didn’t send him a valentine this year. “I really don’t care. That’s not why I do this.”
UPDATE: St. Jude Medical has just issued a detailed statement as follows:
There are a number of ways a lead may fail, including dislodgement, fracture (breaking of the lead), and abrasion (e.g. wear on the lead due to friction against another object). These failures can result in impedance changes, noise, under- and oversensing, an inappropriate shock, an electrical short or, in the most serious cases, a failure to provide therapy. As part of our commitment to communicating with the clinical community about device performance, lead failures are reported in our biannual product performance report, including in the Focus on Clinical Performance section. Failures are associated to some degree with leads from all manufacturers and may also be the result of the harsh environment that these leads must endure.
While no lead is perfect, bench testing has demonstrated that the Optim material is 50 times more abrasion resistant than silicone insulation. Although not mentioned in the manuscript, St. Jude Medical also has the largest prospective, actively monitored lead registries in the industry, including our OPTIMUM registry of Optim insulated leads. Additionally, we announced in March that we have appointed Population Health Research Institute (PHRI), an academic health science research institute, to analyze data from three combined prospective, actively monitored registries involving approximately 11,000 patients enrolled at 292 sites, with more than 5 years and 27,000 patient-years of data, which are documenting the performance of our current-generation leads. In fact, we recently announced that we are expanding our OPTIMUM study follow-up duration to follow patients enrolled in the registry indefinitely.
St. Jude Medical is committed to continuing to make significant investments in technologies and post-market surveillance studies to further advance our insight into the performance of our leads, and to improve patient safety.