ClearFlow said today it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains.
The Anaheim, Calif.-based company said that the device is designed to prevent retained blood syndrome, which can be detrimental to outcomes after cardiothoracic surgery and may require late interventions.
“ClearFlow is committed to rapid technological innovation and this new generation of devices will offer features and benefits never before seen in ClearFlow products. It will also be available in shapes and sizes that previously were not available in our first generation of PleuraFlow devices. Our PleuraFlow active clearance technology system was the first FDA cleared device indicated to maintain chest drain patency and to reduce retained blood for adults and children recovering after heart surgery. We are delighted that the US FDA cleared our latest technology which represents another advance in cardiothoracic surgery care. This is a significant step towards the establishment of a new best practice for post-surgical chest tube patency in the ICU,” CEO Paul Molloy said in a prepared statement.
“Active clearance of chest tubes has been shown in clinical trials to be superior to passive drainage in preventing RBS. The new design helps resist kinks, and allows positioning of the catheters into harder-to-reach areas in the postoperative chest, effectively expanding the use within the field of cardiothoracic surgery,” co-founder Dr. Ed Boyle said in a press release.
Last July, ClearFlow said it launched its PleuraFlow device designed for removing clots from chest tubes used to evacuate shed blood during pediatric cardiothoracic surgeries.