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Studies Suggest St. Jude Device Not Effective

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Miami, FLTwo studies suggest a St. Jude Medical device may not be as effective as thought. The device, known as the St. Jude Amplatzer PFO Occluder was designed to close holes in the patient's heart following a stroke, but two studies suggest the device is no better at preventing repeat strokes in patients than non-surgical treatments. In 2000, certain St. Jude heart valves were recalled after concerns about heart problems linked to the silzone mechanical heart valve. Included in concerns about the reportedly defective heart valve were an increased risk of heart failure, thrombosis and stroke.

The device included in the two recent studies (reported on by Bloomberg Businessweek; 10/25/12), is not the same as the St. Jude Silzone heart device. The studies, which were presented at the Transcatheter Cardiovascular Therapeutics conference, found the St. Jude Amplatzer PFO Occluder was no more effective at preventing repeat strokes than drug treatment, although in one study the effectiveness of the device increased when researchers adjusted for dropout rates.

The strokes that patients with the PFO Occluder experienced were not fatal strokes and physicians have said they would still like the option of using the Occluder on patients for whom it could be effective.

In January 2000, St. Jude Silzone mechanical heart valves were recalled after reports surfaced that the silver coating on the valves could leak, potentially causing heart failure. When the recall was announced, St. Jude recommended patients who had the device implanted only have it removed if they suffered complications, because of the risks associated with surgery to remove the valve.

Lawsuits against St. Jude alleged the coating was used and marketed without being properly tested for side effects and adverse reactions. Just before the recall a study of the safety of the Silzone valve was stopped early because of the increased risk of leakage. The study, called the Artificial Valve Endocarditis Reduction Trial (AVERT), found a 2.76 percent incidence of paravalvar leak in patients who received the Silzone valve, compared with 1.02 percent incidence in patients without the Silzone valve.

As recently as July, 2012, the FDA received an adverse event report from a patient who had the St. Jude Silzone valve replaced—for unknown reasons—with another manufacturer's valve. The surgery occurred without complications. It is not known whether the valve was taken out because of adverse effects or because the patient simply wanted a different valve.

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