Essential Medical announces CE mark submission for MANTA large bore vascular closure device

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Essential Medical has submitted its CE mark application for MANTA, the company’s large bore vascular closure device.  

The company says that its single-arm, 50-patient study “shows conclusively that MANTA successfully achieves immediate haemostasis (median TTH was 24 seconds) in the femoral arterial access site in patients undergoing percutaneous large bore procedures using sheaths ranging from 14F to 24F.” With immediate haemostasis, and a device deployment time of 1–2 minutes, operators say they are seeing 20–30 minutes or greater savings in total procedure time when compared to suture mediated closure devices. There were no (0%) minor and one (2%) major device-related complication based on the VARC-2 definitions.

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