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PleuraFlow chest tube clearance system cleared by FDA

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for the PleuraFlow active tube clearance system developed by Clear Catheter Systems. It is designed to clear chest tubes in patients who have undergone heart and/or lung surgery. These tubes are inserted into the chest to remove air or fluid – if they become clogged blood can build up around the heart and lungs, leading to complications and sometimes death. PleuraFlow uses a specially-designed clearance member that breaks down clots and pulls them out of the tube. Bend, Oregon-based Clear Catheter Systems CE marked the device for sale in Europe in June, and it is also approved in Canada. The firm estimates that the worldwide market for the system is $5bn.

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