St. Jude Durata Defibrillator Lead Failure Rate Low, Study Suggests

New research seems to suggest there is a low failure rate for St. Jude Durata and Riata ST Optim defibrillator leads, which were introduced as a second generation version of the controversial Riata leads that were removed from the market amid reports involving problems with the insulation, where the small wires used to connect an implantable defribrillator to the heart were becoming exposed inside the body. 

In a press release issued last week, St. Jude Medical announced the preliminary findings of a study conducted by the Population Health Research Institute (PHRI), a Canadian academic science institute in McMaster University.

The manufacturer reports that the independent researchers found a very low rate of incidents where the insulation around Durata or Riata ST Optim leads were reported to have failed.

Researchers looked at data on 10,987 leads implanted in patients and reported to several registries. It found that the rates of failure for the Riata ST Optim and Durata leads due to insulation abrasion was 0.06 percent, and the rate of failure due to mechanical reasons was 0.31 percent.

“PHRI’s independent analysis of Optim-insulated defibrillation lead data continues to support the safety and reliability of our Durata leads,” said Dr. Mark Carlson, chief medical officer and senior vice president of Research and Clinical Affairs for the St. Jude Medical Implantable Electronic Systems Division. “We will continue to closely monitor the performance of our high-voltage leads in order to support our efforts to provide safe, reliable devices to physicians around the world.”

Concerns Surrounding St. Jude Defibrillator Lead Failures

The findings come amid recent concerns surrounding the safety of the St. Jude defibrillator leads, which have increased over the past year, since the FDA determined that the manufacturer’s decision to stop selling their Riata and Riata ST defibrillator leads constituted a medical device recall.

Those older leads were removed from the market amid reports of problems where the wires were poking through the insulation, which may cause the defibrillator to fail to deliver a life-saving charge when needed or cause patients to suffer unnecessary shocks.

St. Jude introduced the Riata ST Optim lead in 2006, and subsequently renamed it the St. Jude Durata in 2008. Although these newer leads were introduced with redesigned insulating material, concerns have persisted that similar issues may exist with the Riata ST Optim and Durata leads where the leads may poke through the insulation.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

The agency also indicated at that time that it was ordering St. Jude to conduct additional studies on the potential risk of insulation failures and problems with the debrillator leads, including the newer versions sold under the Riata ST Optim and Durata names.

A number of users who have experienced problems with the recalled defibrillator leads are now pursuing a St. Jude Riata product liability lawsuit against the manufacturer, alleging that manufacturing defects caused the older versions of the leads to feature inconsistent insulation diameters and inconsistent lubcricous interface between the inner and outer insulation, which can lead to problems with abrasion or wear at thinner sites. In addition, the lawsuits allege that St. Jude may have failed to properly cure and sterilize during the manufacturer of the Riata and Riata ST leads, which may have reduced strength of the silicone insulation.

With the Durata leads, St. Jude redesigned the insulating material with a mix of silicone and polyurethane, which the company has called “Optim”.