ClearFlow Executives Comment on Need for New Protocols

Anaheim, CA – January 31, 2017—Clinical study results presented at the Society of Critical Care Medicine (SCCM) 46th Annual Critical Care Congress in Honolulu last week suggest that all heart surgery patients are at risk for Retained Blood Syndrome, not just high-risk patients, as previously assumed. All patients having heart surgery are required to have drainage catheters to remove shed blood from around the heart and lungs in the early hours of recovery following surgery.  Evidence suggests that these drainage catheters, or chest tubes, have a high failure rate due to clogging, leading to what is known as Retained Blood Syndrome (RBS).

Cardiac anesthesia investigators from the Charité – Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine, presented data from an investigation assessing whether risk factors for bleeding or bleeding itself contribute to the predictability of the development of retained blood.

Having already established in previous studies that retained blood has a statistically significant impact on post-surgery patients, including leading to a higher likelihood of mortality, longer ICU lengths of stay, four times higher infection rates and increased cost of care, this new data revealed that in a study of 6,909 cardiovascular surgery patients, it is evident that although the risk of bleeding and bleeding itself appear to predict a higher incidence of RBS related complications, the absence of these factors do not eliminate the risk of this collection of complications.  The investigators concluded that remediation efforts, while focused on the highest risk patients for bleeding, may also need to include lower risk patients to adequately address this problem.

“This study sheds further light on the likelihood of retained blood and related complications after heart surgery, which will help prevention strategies to be further developed,” said Ed Boyle, M.D., cardiothoracic surgeon and founder and chairman of ClearFlow, Inc., a medical device company based in Anaheim, CA.  ClearFlow is the manufacturer of the PleuraFlow® Active Clearance Technology® (ACT®) System – the only FDA cleared device available that enables caregivers to proactively prevent or minimize chest tube occlusions and reduce retained blood.

“These data underscore that there are significant opportunities to further reduce the costs and complications of retained blood in patients recovering from heart surgery” said Paul Molloy, CEO of ClearFlow, Inc.  “This reinforces the approach that prevention of retained blood is preferable to treating it after it occurs, and helps hospitals develop protocols and quality improvement programs to optimally do so.”

The PleuraFlow Active Clearance Technology System is approved for use in the U.S., Europe, Australia, Brazil, Canada, 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 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.

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 PleuraFlow and Active Clearance Technology are registered trademarks of ClearFlow, Inc.

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