St. Jude Medical (NYSE:STJ) released data from of its internal probe of the Riata defibrillator lead showing rates of externalized conductors – which prompted the recall of the product in December 2010 – that are roughly in line with prior studies.
The St. Paul, Minn.-based medical device maker said the
724-patient, 20-site study found externalized
conductors in 9.3% of a smaller-diameter Riata lead and 24.0% of
an older, larger-diameter Riata model.
That’s about the same as the 12% to 33% rates found in other studies published in the European Heart Journal and the Journal of the American College of Cardiology, according to Leerink Swann analyst Danielle Antalffy, who noted that the news could be a boost if it holds true for St. Jude’s next-generation Durata lead.
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STJ shares ticked down half a percent this morning, reaching $38.73 apiece as of about 10:50 EDT.
"We are now focused on collecting longer-term data in the second phase of this study. Our goal is to provide physicians timely and relevant clinical data to best support their patient management decisions," Dr. Mark Carlson, chief medical officer for St. Jude’s cardiac rhythm management unit, said in prepared remarks.
St. Jude said the problem that most often occurs with the recalled Riata leads is inside-out abrasion of the leads’ silicon insulation, "which occurs when the cables housed within the outer insulation of the lead work their way outside of the lead body as the result of movement against the insulation."
"External, or outside-in, abrasion is a known cause of failure across all cardiac leads in the industry, and is different from the inside-out abrasion seen with externalized conductors in some Riata leads," according to a press release. The company plans to run the study for 2 more years with an eye toward helping doctors figure out how best to deal with externalized leads.
"To us, the more meaningful piece of this ongoing study will be what STJ
management calls the ‘second phase’ – the phase of the study that will
determine patient management protocol in the event of an externalized
conductor with Riata," Antalffy wrote in a note to investors this morning. Even more important, she wrote, is how the news affects the prospects for St. Jude’s Durata leads, which use the same diameter wire as the smaller Riata version.
"With Durata more similar to the smaller-diameter 7F Riata lead –
in size, among other characteristics – we’re inclined to view the lower
externalized lead rate in the smaller lead as a potentially positive signal
for Durata. Still, it’s difficult to draw conclusions regarding Durata from
this study given that the study involved Riata leads only," Antalffy wrote.
Last month a report of a single Durata lead failure slashed St. Jude’s share price by 6%, only to be rebuffed by a company investigation that found the failure was due to outside-in abrasion from a disused lead implanted earlier. News of that investigation helped STJ shares regain their value 2 weeks after the first report surfaced.