MASSDEVICE ON CALL — The problems with St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator leads should have been caught sooner, according to a prominent heart doctor.
Dr. Robert Hauser, of the Minneapolis Heart Institute, in an article for the New England Journal of Medicine, wrote that problems with the leads, which remain active in an estimated 79,000 U.S. patients, went uncovered for too long because of lax post-market surveillance.
"St. Jude Medical has the most active post-market surveillance program in the industry for these leads," St. Jude chief medical officer Mark Carlson told Bloomberg. "St. Jude Medical has a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients."
Even so, the St. Paul, Minn.-based med-tech titan can’t detect product defects until the device has already affected thousands of patients, according to Hauser.
"Patients in the U.S. continue to be exposed to under-performing and potentially hazardous medical devices after they have been approved by the FDA, despite multiple recalls and some tragic adverse events," according to Hauser, who was 1 of the physicians who helped uncover problems with Guidant Corp.’s pacemakers after a patient he was treating died. "We are confronted once more with a critical clinical situation in which we have no scientifically valid information to guide us."
The FDA slapped St. Jude with a Class I recall for the Riata leads in December 2011, after the company said the devices failed more frequently than previously reported.
St. Jude recalled the Riata leads, which it stopped selling in 2009, after receiving reports of high rates of “insulation abrasion,” which occurs when the leads’ wires poke through their coating.
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