AtriCure Gains Expanded Labeling For Atriclip, Braces LAA Arm
Zacks Investment Research | Aug 27, 2019 10:50PM ET
Shares of AtriCure, Inc. (NASDAQ:ATRC) hopped 0.22% to close at $26.82 yesterday, subsequent to the company's receipt of the FDA’s 510(k) clearance for additional C claims of its well-acclaimed AtriClip left atrial appendage (LAA) management devices. This FDA approval validates the company's efforts in gaining ground in the field of coronary artery disease and other cardiovascular disorders.
The Labeling Claim and Prospects
The additional indication covers change from occlusion of the LAA to exclusion and also addition of electrical isolation as a labeling claim. Here, ‘exclusion’ shuts off and/or eliminates the appendage from the left atrium. Meanwhile, ‘occlusion’ plugs the opening to prevent flow into the LAA. Per AtriCure, the electrical isolation claim was granted after testing, which demonstrated that when the LAA is excluded using an AtriClip device, the appendage can no longer conduct electrical activity.
Given the fact that approximately 2.5 million adults in the United States suffer AF (with the market estimated to reach $14.68 billion by 2026 at a CAGR of 14.1% from 2018 onward, according to Zacks Investment Research
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