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FDA recommend X-rays for Riata patients

The US Food and Drug Administration (FDA) has issued further guidance relating to the previously recalled implantable cardioverter defibrillator (ICD) leads, manufactured by St Jude Medical.

17 August 2012

The US Food and Drug Administration (FDA) has issued further guidance relating to the previously recalled implantable cardioverter defibrillator (ICD) leads, manufactured by St Jude Medical.

The advice issued by the FDA recommends that patients who have implantable heart defibrillators with Riata and Riata ST leads, manufactured by St Jude Medical, should undergo investigations involving X-rays or other imaging alternatives. The treatment is considered necessary to check for abnormalities with lead insulation, previously highlighted by St Jude Medical in a much publicised recall in November 2011.

The voluntary recall of the Riata and Riata ST leads followed reports indicating problems, involving premature erosion of the insulation around the electrical conductor wires, also known as “insulation failure”. The recent FDA information further states that the lead “may malfunction and lead to inappropriate or no shock therapy and potentially life-threatening abnormal heart rhythms.” Although St Jude Medical ceased selling the leads in late 2010, it is thought that 79,000 leads are still implanted in patients in America. In conjunction with the steps taken by St Jude Medical, the UK Regulator, the Medical and Healthcare Products Regulation Authority (MHRA) issued an urgent medical device alert, concerning all models of the Riata and Riata ST leads, manufactured by St Jude Medical.

Concerns were raised by practitioners at the time of the 2011 recall, emphasising the need for more data to assist with patient management. The advice given to practitioners to date has simply been for regular checks, with X-rays or ECG if a lead failure is suspected. In response to the FDA’s updated advice, St Jude Medical said, “we understand the FDA’s decision to recommend fluoroscopic or X-ray screening of all patients with a Riata lead, in order to establish a baseline of understanding about the incidence rate of externalised conductors.”

The FDA state that their recommendations are supported by several studies, demonstrating that routine imaging of the affected leads may detect previously unrecognised insulation problems. It is hoped that their advice will enable medical practitioners develop individualised patient treatment plans.

A further step is being taken by the FDA to monitor and collect data relating to leads manufactured by St Jude Medical. St Jude Medical is required to conduct post-market surveillance studies, to collect clinical data relating to premature insulation failures. As well as the Riata and Riata ST leads, these monitoring requirements extend to the QuickFlex LV CRT, QuickSite LV CRT and Riata ST Optimum leads. The QuickFlex LV CRT and QuickSite LV CRT leads were also subject to a voluntary recall by St Jude Medical in April 2012.

Jeffrey Shuren, director of the FDA Centre for Devices and Radiological Health stated that “The agency does not have enough information to determine the frequency and timing of insulation failure in these leads; therefore the post-market surveillance studies will ensure that health care professionals and patients get the data they need to better guide clinical management decisions.”

Leigh Day & Co currently represent individuals who experienced problems regarding the St Jude Riata ICD leads. They also represent a large group of individuals who have experienced problems with various Sprint Fidelis model numbers, manufactured by Medtronic Inc.

Information was correct at time of publishing. See terms and conditions for further details.

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Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads Manufactured by St Jude Medical (MDA/2012/061) 10.9.12