ClearFlow has launched PleuraFlow active clearance technology in newer, smaller sizes, for the treatment of paediatric cardiothoracic surgery patients. After receiving clearance from the US Food & Drug Administration (FDA) earlier this year for expanded Indications for Use with the company’s patented technology, ClearFlow developed a new model of the PleuraFlow product for the paediatric market.
The PleuraFlow system is intended to remove clots from chest tubes. The new, smaller-sized options are designed specifically for paediatric applications.
“We commonly hear from paediatric heart surgeons, paediatric intensive care specialists and ICU nurses that they encounter problems with chest tube clogging after heart surgery in children, and sometimes this results in preventable major complications or even fatal consequences. The older makeshift bedside techniques of stripping or milking conventional chest tubes has been shown ineffective to prevent these problems, and can even be harmful, and thus are banned in many hospitals.” says ClearFlow chief executive officer Paul Molloy.
In a study published in the Annals of Thoracic Surgery, smaller 20Fr chest tubes fitted with active clearance technology cleared blood significantly better than larger 32Fr chest tubes without active clearance technology. This was the first demonstration that smaller tubes can drain better than larger tubes if the lumen is preventatively kept clear of clot. The FDA recently cleared the 20Fr system with 4 side holes, which is—according to a company release—ideally suited for infant, preadolescent, and adolescent patients undergoing congenital cardiac surgery. This system is also available in a 20Fr with 6 side holes, as well as 24Fr system when needed for larger paediatric patients.
“There has long been a need to facilitate patency of chest tubes in the smallest diameters used for paediatric heart surgery since the smaller the tube, the more prone it is to occlude,” adds cardiothoracic surgeon and ClearFlow co-founder Ed Boyle.