The FDA's unexpected decision in mid-August to issue market clearance for Concentric Medical Inc. 's Merci retriever system, the first medical device approved by the agency to treat acute ischemic stroke (AIS), is a dramatic success for Concentric. It also boosts a field that has seen its share of disappointment and has only one other FDA approved treatment option.
The agency's decision was a surprise to many because just six months ago, the FDA's Neurological Devices Panel, while agreeing that the Merci system appeared efficacious, criticized Concentric for not...