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Medical Devices / Submissions and Approvals

SentreHeart’s Left Atrial Appendage Closure Device Gets CE Mark

May 6, 2019
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SentreHeart earned the CE Mark for the 50mm version of its LARIAT-RS left atrial appendage (LAA) closure device.

Using imaging guidance, the LARIAT delivers a suture loop at the base of the LAA. Over time, the appendage disappear, so it is no longer a source of blood clots in patients with atrial fibrillation.

SentreHEART is conducting the aMAZE trial in up to 65 centers in the United States that seeks to show that the LARIAT procedure followed by a catheter ablation can reduce the incidence of recurrent atrial fibrillation.

The new 50mm device is now available in Europe along with the 45mm version.

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