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Minneapolis Heart Institute Foundation welcomes Europace publication of Optim™ lead insulation paper
Date:8/21/2012

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"We know new leads need to be implanted for years before useful reliability data can be collected," stated Dr. Hauser. "We are still in the process of gathering information about Optim, so these are not definitive data, and at this point in time we do not see a direct risk to patients."

The purpose of this study was to determine if Optim, a unique co-polymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator leads from abrasions that cause lead failure. The FDA's Manufacturers and User Device Experience (MAUDE) database search returned 15 reports for Riata ST Optim and 37 reports for Durata leads, which were submitted by SJM based on its analyses of returned leads for clinical events that occurred between December 2007 and January 2012. Eight of 15 Riata ST Optim leads had can abrasions and 3 abrasions were caused by friction with another device, most likely another lead. Twelve Durata leads had can abrasions, and six leads had abrasions caused by friction with another device. The paper concludes that Riata ST Optim and Durata ICD leads have failed due to insulation abrasions and that Optim did not prevent these abrasions, which developed up to four years after implant. The paper recommends that studies are needed to determine the incidence of these failures and their clinical implications.


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Contact: Steve Goodyear
sgoodyear@mhif.org
612-863-1658
Minneapolis Heart Institute Foundation
Source:Eurekalert

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