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Photo: Fractured Riata Lead, University. Pittsburgh Medical Center

Data released today by St. Jude Medical (NYSE: STJ) shows that persistent problems with its recalled Riata defibrillator leads increased in the second half of last year, despite the company's attempts to shift its focus to its updated Durata On the lead series.

Compared with the company's last major performance report released in November last year, the "conductor break" rate has risen by 4.3%. According to the report released today, the "insulation damage" rate has risen by 24.4%, and the overall failure rate has risen by 12.3%.

The following are some key failure data of the Riata leads recalled in the St. Jude Medical performance report released last year and today:

In a statement sent via email to MassDevice.com, St. Jude stated that reporting additional details in the latest performance report is laborious, admitting that these reports underestimate the severity of the problem.

The company said: "That's why we have included a special section in this version of PPR that focuses on the performance of our high-voltage leads and provides more details." "We have also expanded our Riata wire evaluation study to include approximately 700 Patients and are finalizing the preliminary results on the incidence of externalized conductors. We hope to compile and communicate the preliminary results report on the incidence of externalized conductors before the end of June 2012. The study will continue to follow patients to evaluate in the future The performance of wires with externalized conductors within two years to provide further information for patient management."

Last month, when St. Jude and CEO Daniel Starks contradicted a study by renowned cardiologist Dr. Robert Hauser, the controversy over Riata's clues made headlines. The study showed that 22 deaths were related to clues. The data released today seems to confirm that the leads are prone to breakage, especially considering that the performance report underestimates the true number of failures. That's because they only track failures reported by doctors to St. Jude, which means an unknown number of incidents have not been reported.

"It's still at a fairly low level, but that doesn't mean we like it," Dr. Bruce Wilkov, an electrophysiologist at the Cleveland Clinic and a member of the St. Jude's Independent Medical Advisory Board, told the Wall Street Journal. "In its essence, this is an underestimation of the problem."

The Riata incident began in September 2011. A small Irish study reported that the revision surgery of the Riata lead was higher than previously reported. A month later, Starks lashed out on TV against its main competitor, Medtronic (NYSE: MDT) and its alleged attempt to harm the market's prejudice against St. Jude.

However, more than a month after Starks questioned it, the company was forced to admit that the Riata revision rate was higher than the revision rate previously reported, and in December 2011, the FDA listed the device as a Class I recall.

St. Jude has begun to phase out its Riata and Riata ST leads in December 2010 because of concerns that their electrical insulation may cause equipment failure, but at the time the FDA did not consider the matter to be recalled, a company spokesperson told the Wall Street Journal at the time .

Then, as a well-known cardiologist linked Riata's study to 22 deaths was published online in the Journal of the Heart Rhythm Society, things started to get interesting. By late March, St. Jude disputed the results of Dr. Robert Hauser's research. On Friday, April 6, the company asked the magazine to withdraw the report (the request was immediately rejected), and during the following weekend, Starks reiterated his allegations that cross-city rival Medtronic supports a Saint jude.

Medtronic subsequently released its own analysis, confirming Hauser's statistics on the number of deaths caused by its Quattro clues, which caused a quick and unusual reaction from St. Jude, and the company announced its own statistics on the number of deaths from Quattro.

Dr. Edward Schloss, director of cardiac electrophysiology at Christ’s Hospital in Cincinnati and an Ohio cardiologist, told MassDevice.com: “In the 19 years I have been in this field, I don’t remember seeing more controversial and controversial issues among medical device companies. Open controversy."

Submitted as follows: News Okay, the recall is marked as: heart rhythm management, stjudemedical

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