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Late last week, a new academic paper published in the Pacing and Clinical Electrophysiology journal found that St. Jude Medical's Durata ICD lead is less prone to lead externalization.

June 13, 2013

2 Min Read
Report Finds St. Jude's Durata ICD Lead Not Prone to Lead Externalization

On June 3, an academic paper brought not-so-welcome news about St. Jude Medical's ICD lead Durata that many believe is likely to fail like its predecessor - the recalled Riata family of leads.

However, four days later, a new report published in the Pacing and Clinical Electrophysiology (PACE) journal, the same publication that contained the negative report, found that the lead is less prone to lead externalization where the cables poke through the lead insulation. That's according to a research note, issued Monday by RBC Capital Markets' senior analyst Glenn Novarro.

Here's what Novarro wrote about the paper authored by a cardiologist, Dr. Ernest Lau:

Dr. Lau’s report indicates that externalized conductors are not an issue for Durata given the Optim coating, which provides “extra resistance against lumen wall indentations.” In his research, Dr. Lau details a model for determining what he coins “conductor cable externalization with protrusion (CCE).” He notes that minimizing CCE risk involves pushing the cable lumens towards the center of the lead body and reducing their sizes in the process.

However, Novarro notes that while this is the argument also forwarded by St. Jude Medical, the paper does not address another mechanism that can cause the lead to fail.

"The failure mechanism that is more concerning is internal abrasion of a RV high-voltage cable, which when coming in contact with a proximal shocking coil can cause a short-circuit," Novarro wrote in the note. "We believe the concerns in the electrophysiology community have moved away from identifying externalized cables as an issue for Durata to internal abrasion issues." 

This also leads to the potential for a Durata recall, which Novarro believes won't happen this year. 

"Bottom-line, while we do not forecast a Durata recall in 2013, we do not believe the risk is fully off the table for next year given the growing number of internal abrasion reports. As a result, we continue to expect STJ to underperform its cardio peers," Novarro concluded.

-- By Arundhati Parmar, Senior Editor, MD+DI 

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