ClearFlow, Inc. has announced a full market release for the 20Fr SEDL version of the PleuraFlow® Active Clearance Technology® System for the treatment of pediatric cardiothoracic surgery patients. The SEDL refers to the “shorter effective drainage length,” which facilitates placement of the PleuraFlow chest tube in the smaller chests of pediatric patients. ClearFlow received clearance from the United States Food & Drug Administration (FDA) as well as the CE mark last year for expanded Indications for Use with the company’s patented technology and developed a new model of the PleuraFlow product for the pediatric market.
After a successful limited market release in the US, Germany, Switzerland and the UK, ClearFlow has expanded distribution of the product to all pediatric cardiac surgery centers.
Inadequate drainage due to chest tube clogging is a problem for many heart surgery patients of all ages, especially for smaller diameter tubes required for pediatric heart surgery.
“We commonly hear from pediatric heart surgeons, pediatric 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,” said ClearFlow CEO Paul Molloy. “The older makeshift bedside techniques of stripping or milking conventional chest tubes have been shown ineffective to prevent these problems, and can even be harmful, and thus are banned in many hospitals. We are pleased to announce that Pediatric Cardiac Surgery Centers can now adopt preventative protocols to routinely clear chest tubes of clogging with a proven, FDA cleared and CE marked medical device.”
“There has long been a need to facilitate patency of chest tubes in the smallest diameters used for pediatric heart surgery since the smaller the tube, the more prone it is to occlude,” added cardiothoracic surgeon and ClearFlow co-founder Ed Boyle, M.D. “Expanding the product offerings to facilitate prevention of chest tube clogging in children requiring complex heart operations is an important step to meet this critical unmet need.”
In a study published in the Annals of Thoracic Surgery, smaller 20 Fr chest tubes fitted with Active Clearance Technology® cleared blood significantly better than larger 32 Fr chest tubes without Active Clearance Technology®.
