St. Jude Medical Inc.'s Riata, a cable used in heart defibrillators, is the latest example of a defective medical device that wasn't spotted quickly enough because U.S. surveillance systems are lacking, according to an article in the New England Journal of Medicine.
The device maker stopped selling the wires known as leads in December 2010, then the Little Canada-based company recalled the products a year later because they could break through Riata's insulation coating and cause a potential failure. Still, 79,000 of the devices are inside U.S. patients, with questions remaining about their risks, said Robert Hauser, a cardiologist at the Minneapolis Heart Institute.
St. Jude and U.S. regulators aren't conducting the research needed to guide treatment for patients with Riata leads, though technology is available to do so. Surveillance systems weren't in place to detect the defects early, even after the need for them became clear when Fridley-based Medtronic Inc. halted sales of its Sprint Fidelis leads in 2007 because of their potential to fracture, Hauser said.
"Patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration, despite multiple recalls and some tragic adverse events," Hauser wrote, in the article released Tuesday by the medical journal. "We are confronted once more with a critical clinical situation in which we have no scientifically valid information to guide us."
St. Jude officials on Tuesday pointed to several "inaccuracies" in Hauser's article. First, officials pointed out that St. Jude started a 500-patient Riata Lead Evaluation Study in December 2011 to get more information on how often the wires break free from the insulated cables; evaluate any related electrical abnormalities; and help guide future patient management. A website was introduced to improve communication with physicians and provide additional information, the company said in a statement.
"St. Jude Medical has the most active post-market surveillance program in the industry for these leads," said Mark Carlson, chief medical officer of St. Jude, in an e-mailed statement.
Second, St. Jude disagreed with Hauser's contention that the current surveillance system doesn't detect defects until thousands of patients have been exposed to a new technology. Hauser wrote that there is little information to ensure the safety of any new products, including the St. Jude Durata lead that replaced Riata, or guide the care of patients who receive potentially harmful devices, he said. As a result, doctors react ineffectively and perhaps dangerously, he said.
But St. Jude said Tuesday that it did, indeed, start assessing the performance of its Optim/Durata leads five years ago, and "those studies now include 10,836 leads."
