FDA-Cleared System for Pediatric Cardiothoracic Surgery Launched
Anaheim, CA – July 26, 2016 — ClearFlow, Inc., a medical device company based in Anaheim, California, has announced that its PleuraFlow® Active Clearance Technology® is now available for the treatment of pediatric cardiothoracic surgery patients. After receiving clearance from the United States 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 pediatric market.
All patients undergoing heart surgery have some degree of bleeding, and thus, all patients require chest tubes to evacuate shed blood from around the heart and lungs in the early hours after surgery. The problem is that chest tubes often clog, which can limit the ability to evacuate shed blood. This can lead to complications including retained blood around the heart and lungs. The composite of drainage-related complications that are detrimental to outcomes after cardiothoracic surgery and that may require early or late intervention to remediate is known as Retained Blood Syndrome (RBS). These clinical complications have significant economic consequences, including higher costs of care for patients, hospitals, and society at large.
Inadequate drainage due to chest tube clogging is especially a problem for smaller diameter tubes required for pediatric heart surgery. When ICU care providers are concerned with chest tube clogging, they often resort to makeshift bedside techniques to strip or milk out clots, or break the sterile field and advance suction catheters or balloon catheters into the tube in an attempt to re-open them after they have clogged. These techniques are ineffective and potentially harmful.
The PleuraFlow System is a medical device that removes clots from chest tubes. A clogged chest tube can lead to retained blood around the heart and lungs. The new, smaller sized options are designed specifically for pediatric applications.
“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,” said ClearFlow CEO Paul Molloy.
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. This was the first time it was demonstrated that smaller tubes can drain better than larger tubes if the lumen is preventatively kept clear of clot. The FDA recently cleared a 20 Fr System with 4 side holes, which is ideally suited for infant, preadolescent, and adolescent patients undergoing congenital cardiac surgery. This System is also available in a 20 Fr with 6 side holes, as well as 24 Fr System when needed for larger pediatric patients.
“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.”
About ClearFlow, Inc.
ClearFlow, Inc. is an Anaheim, CA based medical device company that has developed a patented active blood and fluid evacuation system to speed recovery, reduce complications and lower healthcare costs related to medical tube obstruction. The company has been awarded several prestigious awards, including the European Association of Cardiothoracic Surgeons Techno-College Innovation Award for worldwide innovation that has the potential to change the standard of care in heart and lung surgery, and the Innovations in Cardiovascular Interventions Award, among others.
PleuraFlow and Active Clearance Technology are registered trademarks of ClearFlow, Inc.