Artificial embolization devices
This article was originally published in The Gray Sheet
Executive Summary
Preamendment Class III artificial embolization devices for neurological use are unanimously (7-0) recommended for downclassification to Class II at a June 12 Neurological Devices Panel meeting. The devices obstruct blood flow to an aneurysm or other vascular malformation. The recommendation is based on data submitted to the agency by three manufacturers following an FDA call for data under Sec. 515(i) of device law and presented to the panel by FDA. Panel members note that the products have been used safely and effectively for more than 20 years. Suggesting that additional labeling should be required that emphasizes that only specially trained surgeons use the product, the panel agrees that special controls would be sufficient to ensure safety
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