ClearFlow Announces Additional Positive US Clinical Trial Results at the 2018 NTI Critical Care Exposition
Reduction of Hospital Complications and Resource Utilization after Heart Surgery Demonstrated with Use of the PleuraFlow® ACT® System.
Boston, MA – May 29th, 2018 — ClearFlow, Inc., a medical device company based in Anaheim, California, has announced that positive clinical trial results were presented at the National Teaching Institute (NTI) & Critical Care Exposition 2018 annual meeting on May 23rd, 2018 in Boston, MA. The findings were presented by the study principal investigator, Dr. Yvon Baribeau, of Catholic Medical Center in Manchester, New Hampshire, in a presentation titled “Active Clearance of Chest Drains Reduces Pleural Effusions and ICU Resources in patients undergoing Cardiac Surgery.”
This data stems from a trial evaluating the use of the PleuraFlow® Active Clearance Technology® (ACT®) System to prevent retained blood complications in heart surgery patients. PleuraFlow® is a medical device used at the bedside in the ICU that enables caregivers to proactively maintain chest tube patency following cardiac surgery. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood, which is accepted by physicians as contributing to many common complications after surgery, including post-operative atrial fibrillation (POAF), pleural effusions and pericardial effusions.
The primary endpoint of this study was reduction in the composite of retained blood syndrome, which includes any of the following interventions performed during index hospitalization and 30-days readmission: Re-exploration for bleeding, delayed sternal closure and pleural and pericardial interventions. The results demonstrated a statistically significant reduction of interventions for retained blood syndrome by 58.7% in the treatment group, including a 63.2% reduction in thoracentesis, a 66.7% reduction in re-exploration for bleeding, a 29.1% reduction of postoperative atrial fibrillation (POAF) and a 73.0% reduction in infections. As seen in prior clinical trials, patients treated with the PleuraFlow® System experienced a reduction in postoperative length of stay (LOS) by one day as well as a marked reduction in the cost of care, providing a strong economic justification for adopting this technology.
“The results of this study again represent clear validation that active clearance of chest tubes following heart surgery reduces clinical complications of retained blood and reduces hospital resource utilization and costs related to treating complications such as POAF, infection, use of blood products and length of stay in the ICU and hospital,” said Paul Molloy, CEO of ClearFlow. “The PleuraFlow System is the only product on the market shown to reduce healthcare costs by lowering the rates of these frequent complications.”
“This is the now the fifth positive clinical trial demonstrating that proactive maintenance of chest tube patency after cardiac surgery reduces complications related to retained blood,” said Edward Boyle, a cardiothoracic surgeon, and ClearFlow founder and chairman. “In addition, this data again shows that by clearing chest tubes to achieve more efficient evacuation of shed mediastinal blood there is an associated reduction in postoperative atrial fibrillation (POAF), which is one of the most common complications after cardiac surgery.”
The PleuraFlow® Active Clearance Technology® System is approved for use in the U.S., Europe, Australia, Brazil, Canada, Mexico and other countries in Asia and the Middle East.
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 2017 Global Frost & Sullivan Award for New Product Innovation, 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, Active Clearance Technology, and FlowGlide are registered trademarks of ClearFlow, Inc.