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

MINNEAPOLIS, MN August 21, 2012 The Minneapolis Heart Institute Foundation, an international leader in cardiovascular research, today announces the online publication of a study in EP Europace that raises serious concerns about St. Jude Medical defibrillator leads. The study found that a new copolymer of silicone and polyurethane (Optim) might not prevent insulation abrasions that can result in electronic malfunction. The paper is authored by Foundation researchers Robert Hauser, Raed Abdelhadi, Deepa McGriff and Linda Retel, and it is another in a series of Foundation publications that have reported significant problems with defibrillator leads, including recalled Riata and Riata ST leads from St. Jude Medical (SJM).

Defibrillators are implanted in patients to prevent sudden cardiac death.

Defibrillator leads deliver energy to the heart in order to stop abnormal, rapid heartbeats that can cause blackouts and death. These leads must be able to function properly during years of service in the body.

The paper "Failure of a Novel Silicone-Polyurethane Copolymer (Optim) to Prevent ICD Lead Insulation Abrasions" appears on the journal's web site and is available at http://europace.oxfordjournals.org/content/current.

"Our paper presents data that suggest Riata ST Optim and Durata ICD leads may not be adequately protected from insulation abrasions caused by friction with the pulse generator can or other leads in the heart," stated Dr. Hauser. "We need studies to determine the incidence of these failures and the implications for patients. At this time we do not believe that patients should be unduly concerned or their leads replaced. We do believe that patients with these leads should be evaluated regularly, as recommended by their physicians."

This study follows on the heels of a recent FDA order that St. Jude Medical launch new studies focusing on the performance of its Riata and Duranta defibrillator leads. '/>"/>

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

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