Minneapolis, Minnesota -- The Minneapolis Heart Institute Foundation has published a study that raises serious concerns about St Jude Medical defibrillator leads.
The study, published online on EP Europace, found that St Jude's Optim copolymer of silicone and polyurethane might not prevent insulation abrasions that can result in electronic malfunction, the foundation claims.
The paper is one 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.
"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," commented Dr Robert Hauser, one of the author's of the paper, in a 21 Aug news release.
He noted, "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 is in line with recent US Food and Drug Administration advice reported by UTI. The FDA also requires that St Jude Medical launch new studies focusing on the performance of its Riata defibrillator leads.
The purpose of the foundation's 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 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.