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FDA Panel: Heart Closure Device Safety Data Demands Further Study

More study is required to make sense of the adverse event rates associated with two marketed atrial septal defect occluders, a May 24 FDA panel concluded. St. Jude Medical, in particular, should start a new prospective study for its Amplatzer device, the panel recommends.

Additional analysis is needed to assess the safety profile of St. Jude Medical Inc.’s Amplatzer and WL Gore & Associates Inc.’s Gore Helex transcatheter atrial septal defect (ASD) occluders in light of post-market adverse event data pointing to unexpected rates of tissue erosion and device fracture, FDA’s Circulatory System Devices Panel concluded May 24.

Chief among the panel’s recommendations is that FDA should order St. Jude to conduct a “section 522” post-market surveillance study with a prospective, case-controlled design to gain a better understanding of what might be driving the roughly 0

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