New Published Clinical Trial Results Confirm that PleuraFlow Enables Improved Quality and Cost of Care for Cardiac Surgery Patients

Reduction of Patient Complications and Hospital Resource Utilization After Heart Surgery Demonstrated with Use of the PleuraFlow ACT System

IRVINE, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Irvine, California, has announced positive clinical trial results published in the peer-reviewed Journal of Cardiothoracic Surgery. The trial evaluated the use of the PleuraFlow^® Active Clearance Technology^® (ACT^®) System in prevention of retained blood complications in heart surgery patients.

PleuraFlow is a medical device used at the bedside in the ICU that enables clinicians to proactively maintain chest tube patency following cardiac surgery without breaking the sterile field. 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 findings are reported by the study’s principal investigator, Dr. Yvon Baribeau, of Catholic Medical Center in Manchester, New Hampshire, in the article, “Active Clearance of Chest Tubes is Associated with Reduced Postoperative Complications and Costs After Cardiac Surgery: A Propensity Matched Analysis.” As seen in prior clinical trials, patients treated with the PleuraFlow System experienced a reduction in postoperative length of stay (LOS) by one day and a reduction in postoperative atrial fibrillation (POAF) of 32.4%. In addition, a reduction in the average cost of care of $2,696, that included cost of the PleuraFlow System, was associated with utilization of the System, further demonstrating the favorable economic outcome enabled by ACT.

“The results of the trial, combined with earlier research, mark a breakthrough advancement in prevention of retained blood following cardiac surgery, and enhanced patient recovery,” said Louis Perrault, MD, Ph.D., Chief of Cardiac Surgery at the Montreal Heart Institute, Montreal, Canada and Co-Principal Investigator of the study. “Until now, there has not been an effective means for enabling prevention of these costly complications, while easily integrating into clinical workflow. Our findings, combined with other groups’ studies, describe a compelling vehicle for improving patient care and economic outcomes.”

“It is gratifying to see the continuation of evidence demonstrating the cost and quality of care gains associated with application of the PleuraFlow ACT System,” said Paul Molloy, President and CEO of ClearFlow. “The data again shows that by more effectively clearing chest tubes following cardiac surgery, there is an associated reduction in POAF, which is the most common complication after cardiac surgery. We appreciate the opportunity to partner globally with clinical teams in enabling enhanced recovery for cardiac surgery patients. And we look forward to continuing to support healthcare providers engaged in ERAS Cardiac and cardiac surgery outcomes improvement initiatives.”

About ClearFlow, Inc.

ClearFlow, Inc. is an Irvine, 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.

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