The Anaheim, Calif.-based company said it won FDA 510(k) clearance earlier this year expanding the indications of use for a PleuraFlow system for pediatric patients.
"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. 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. We are pleased to announce that children's hospitals can now adopt preventative protocols to routinely clear chest tubes of clogging with a proven, FDA cleared medical device solution," CEO Paul Molloy said in a press release.
ClearFlow said the device is designed to work with the smaller diameter tubes required for pediatric heart surgery and to avoid techniques for avoiding fclots that can break the sterile field and be potentially harmful.
"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. 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," co-founder Dr. Ed Boyle said in a prepared statement.
The post ClearFlow launches PleuraFlow pediatric cardiothoracic surgery device appeared first on MassDevice.
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