AtriCure Receives Clearance for Expanded Labeling Claims for AtriClip Devices
Clinical evidence demonstrates that AtriClip® devices exclude and electrically isolate the left atrial appendage
AtriClip devices are the most widely implanted left atrial appendage management devices on the market, having been used in more than 190,000 procedures worldwide. Over the past several years, new iterations of the AtriClip device have been developed and brought to market. These include enhancements to make the devices less invasive, amenable to a wider range of patient anatomies, and adaptable to varying operator preferences and techniques. These new labeling claims reflect that AtriClip devices exclude the appendage resulting in eliminating it as a source of electrical activity through the process of ischemic necrosis. The safety and effectiveness of AtriClip devices in rhythm control management of an atrial arrhythmia, either alone or in combination with ablative treatment, has not been established.
“We continue to demonstrate our leadership in the LAA management space by expanding our labeling claims for AtriClip devices,” said
“Historically, the surgical amputation of the left atrial appendage in a cut-and-sew fashion was considered to be the gold standard for LAA management," said
"Our research has defined a clear benefit of the electrical isolation of the LAA," said
This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/fls as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We do not undertake to update our forward-looking statements. This document also includes forward-looking projected financial information that is based on current estimates and forecasts. Actual results could differ materially.
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