Atritech's Watchman anti-stroke device requires further study
This article was originally published in The Gray Sheet
Executive Summary
Firm's left atrial appendage closure technology requires a confirmatory safety and efficacy study to support FDA approval for treatment of patients with atrial fibrillation at risk of stroke and eligible for anticoagulation therapy, Atritech says March 18 after receiving a letter from the agency. The company expects to start the study later this year after it finalizes its design with FDA. Atritech announced its PMA submission for the device in August 2008, and an FDA advisory panel narrowly endorsed approval the following April (1"The Gray Sheet" April 27, 2009). The panel's chairman subsequently warned that long-term data was needed for routine use in stroke prevention (2"The Gray Sheet" June 1, 2009)
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