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Study Raises New Concerns On St. Jude Durata Lead Wires | cialis online

Study Raises New Concerns On St. Jude Durata Lead Wires

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A new study is raising new concerns about St. Jude’s Durata lead wires. The devices shock irregular heart rhythms back to a normal rhythm.

According to the Wall Street Journal, some of the design changes made to the new Durata heart devices did not stop potentially life threatening problems that were issues with earlier, recalled device versions. The study on which the Journal based its report was published online, yesterday, in Europace.

Conducted by Robert G. Hauser, a device-safety watchdog with the Minneapolis Heart Institute, the study revealed 52 instances of Durata and Riata ST Optim defibrillator lead failures; one patient death was reported. The cases were reported by St. Jude to the U.S. Food & Drug Administration (FDA), and can be found in a public database. The Journal noted that these voluntary reports do not reflect the full rate of the problems.

The research concluded that many problems were caused when the leads rubbed against other objects. Leads are wires that connect the heart to implantable defibrillators. Device insulation can wear when the leads rub against defibrillators, which are about the size of a matchbox, The Journal explained.

The study discovered three Durata and one Riata ST Optim failure, all caused by internal insulation problems, said The Journal. Dr. Hauser pointed out that the failures also seemed similar to the failures that led to last year’s recall of St. Jude’s older Riata leads. “For me it’s a red flag,” Dr. Hauser said. Lead recalls have impacted hundreds of thousands of patients, which is why, he said, that physicians should use leads with proven safety records. “If there’s a doubt about a lead, and there’s an alternative, why would you select the lead that’s in question?” Dr. Hauser told The Journal.

One issue is if leads coated with Optim, a new insulation material, are longer lasting when compared to the struggling Riata series, as St. Jude has argued. More data are needed, said Dr. Hauser. “We welcome ongoing discussion and research about the performance of our products,” St. Jude told The Journal. “To date, the accumulation of data continues to support the overall safety and reliability of our Durata leads.” Meanwhile, earlier this year, Dr. Hauser published a paper linking Riata failures to 20 deaths. St. Jude strongly disagreed with his study and requested a retraction from the journal Heart Rhythm. The journal stood by Dr. Hauser’s research, said The Journal.

As NewsInferno noted, St. Jude stopped selling the Riata lead line in late 2010, warning surgeons against using the line because they were poking through their insulation. This can cause a defibrillator to emit unnecessary shocks to a patient’s heart, or, worse, to fail to emit a life-saving electrical impulse to the heart when needed. In December 2011, the FDA deemed St. Jude’s medical device recall a Class I, its most serious designation. St. Jude said some 128,000 patients, worldwide, still use the Riata lead.

Durata and Riata ST Optim leads replaced the recalled Riata-series leads, said The Journal. According to the FDA, St. Jude renamed the Riata ST Optim with the Durata name in 2008, following some small changes; however, the agency noted that the devices are structurally similar. St. Jude argues that they are different.

NewsInferno recently wrote that federal health regulators warned that patients with implantable cardiac defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices connected to their hearts via St. Jude’s Riata or Riata ST lead wires must receive x-rays or other imaging tests. The agency said the screening is necessary to check for St. Jude Riata lead wire insulation abnormalities. The FDA has also asked St. Jude to conduct studies into the scope of Riata lead failures, as well as to its Durata-series ICD leads and its QuickSite LV and QuickFlex LV CRT leads.

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