www.fdanews.com/articles/186390-trans-apical-access-and-closure-device-receives-ce-mark
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Trans-Apical Access and Closure Device Receives CE Mark
April 12, 2018
HeartStitch’s trans-apical access and closure device received a CE Mark for structural heart procedures and closure.
The company expects to launch the product to the European market in the fall, followed by the United States.
The device, which is suture-based, imitates surgical closure without requiring open heart surgery or open surgical access to the heart between the ribs while mending defects in the left ventricle.