Design changes to a key Little Canada-based St. Jude Medical Inc. heart device, including an added layer of insulation to reduce the risk of abrasions, do not prevent defects that could lead to device failure and death. That's according to prominent cardiologist Robert Hauser of Abbott Northwestern Hospital in Minneapolis who made the comments in his study published in the medical journal Europace. He tells the Pioneer Press, "I can't say the Durata lead is bad. I just can't say that it's good."
This is the second time Hauser has looked into potential problems with St. Jude Medical leads, the Star Tribune notes. In March, he published a study in HeartRhythm Journal that linked at least 20 patient deaths with high-voltage failures in Riata leads.
Last week, the Food and Drug Administration recommended that patients who had received an earlier generation of St. Jude leads undergo imaging tests to determine if the device is beginning to fail, New York Times reports. It also ordered St. Jude Medical to conduct additional studies on both the older generation of leads.
Last year St. Jude recalled its older-model Riata defibrillator leads amid reports that the silicone coating around the wires eroded at a higher-than-expected rate, Reuters reports