— ClearFlow Executives Comment on Need for New Protocols —

Anaheim, CA – April 13, 2016—Clinical data presented at the Society of Cardiovascular Anesthesiologists (SCA) 2016 Annual Meeting and Workshops in San Diego last week indicated that Hospital Acquired Infections (HAI) are 75% more likely to occur in patients with interventions for Retained Blood Syndrome (RBS) after heart surgery than in patients who do not have RBS.

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 has shown that these drainage catheters have a high failure rate due to clogging, leading to RBS.

Cardiac anesthesia investigator Dr. Felix Balzer of Charité – Universitätsmedizin Berlin’s Department of Anesthesiology and Intensive Care Medicine presented specific data revealing the role that retained blood plays in hospital acquired infections after heart surgery. Among the findings from this study of 6,909 cardiovascular surgery patients were:

• Patients with interventions for retained blood had a four-times increase in overall infection rate when compared to patients without interventions for retained blood (from 4% to 16%);
• Patients with interventions for retained blood had an increased in pneumonia (from 1% to 9%);
• Patients with interventions for retained blood had an increase in sepsis (from 1% to 7%);
• Patients with interventions for retained blood had statistically significant increases in Clostridium difficile, superficial wound, deep wound, and urinary tract infections;
• The costs to treat these complications as reported in the literature are also significant. For example, the average cost to treat HAI infection after cardiac surgery is about $40,000 (J Am Coll Cardiol. 2015;65(1):15-23. doi:10.1016/j.jacc.2014.09.079)

“We now have additional real life clinical evidence that patients with interventions for retained blood have a significantly greater likelihood of HAIs compared to patients without retained blood,” said Ed Boyle, M.D., Cardiothoracic surgeon and founder and chairman of ClearFlow, Inc., a medical device company based in Anaheim, CA. “We also know what kinds of specific infections these patients are facing – with data indicating a 89% increase in pneumonia, a 90% increase in sepsis, an 88% increase in C. difficile colitis, a 87% increase in superficial wound infections, a 90% increase in deep wound infections and a 87% increase in urinary tract infections, among others.”

“These clinical data underscore the opportunity to dramatically help reduce hospital acquired infections in patients recovering from heart surgery,” said Paul Molloy, CEO of ClearFlow, Inc. “Programs and protocols to reduce retained blood may significantly reduce the number of infections patients face after surgery, which could, in turn, reduce costs. This data presented at SCA last week highlights the urgent need to address the prevention of RBS. Fortunately, Active Clearance Technology such as our PleuraFlow System, provides an easy to use, inexpensive solution to the problem that has already been shown to significantly lower the need for interventions due to RBS-related complications after cardiac surgery.”

ClearFlow is the manufacturer of the innovative 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— a known contributor to postoperative atrial fibrillation (POAF) and other RBS complications which can increase length
of stay (LOS), mortality rates, and hospital readmissions after heart surgery.

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.

Media Contact:
Paul Williams
310/569-0023
paul@medialinecommunications.com