ClearFlow, Inc. Announces Positive US Clinical Trial Results
Reduction of Hospital Complications and Resource Utilization after Heart Surgery Demonstrated with Use of the PleuraFlow® ACT® System.
New York City, NY – August 21, 2017 — ClearFlow, Inc., a medical device company based in Anaheim, California, announced today that positive clinical trial results were presented at the International Coronary Congress (ICC) 2017 annual meeting on August 18th, 2017 in New York City, NY. 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 Retained Blood and ICU Resources after Off-Pump Coronary Artery Bypass 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.
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 60.4% in the treatment group, including a 70% reduction in thoracentesis, a 33.7% reduction of postoperative atrial fibrillation (POAF) and a 65.6% reduction in infections. As seen in prior clinical trials, patients treated with the PleuraFlow® System also had a statistically significant reduction in their overall hospital length of stay (LOS) by 1 day.
“The results of this study represent clear validation that active clearance of chest tubes following heart surgery reduces clinical complications of retained blood and potentially 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,” added Molloy.
“This is the fourth 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 further 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,” added Boyle.
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.