ClearFlow, Inc., a medical device company based in Irvine, California, has announced positive clinical trial results presented at the 2020 Virtual Program of the Annual Eastern Cardiothoracic Surgical Society Conference (ECTSS) on October 8th. The trial evaluated the use of the ClearFlow’s PleuraFlow® Active Clearance Technology® (ACT®) System in the prevention of retained blood complications in heart surgery patients.
The findings, titled “Better Pericardial Drainage After Cardiac Surgery Leads to Better Outcomes,” were presented by Dr. Meghan Kelly of the Division of Cardiothoracic Surgery at Washington University School of Medicine in St. Louis, at the 2020 Virtual Program of the Annual Eastern Cardiothoracic Surgical Society Conference. The study was awarded top honors by the ECTSS Scientific Program Committee for most valuable research.
As demonstrated in multiple propensity-matched studies, patients treated with the Active Clearance Technology experienced a significant reduction in reinterventions for complications caused by retained blood (91% reduction) as well as reduced infection rates and the need for blood products.
“As cardiac surgeons, chest tube drainage is a routine part of guarding against tamponade after heart surgery. However, there may be more beneficial effects to keeping the pericardial space cleared of blood and blood breakdown products than just preventing tamponade,” said Dr. Spencer Melby, Program Director and Associate Professor of Surgery, Division of Cardiothoracic Surgery, Washington University School of Medicine/Barnes-Jewish Hospital. "It appears that our patients who had chest tubes with a mechanism to keep them patent had some additional benefits. They needed fewer postoperative interventions for complications related to retained blood in the chest after surgery compared to historical control patients."
“This study demonstrates the remarkable effect that improved pericardial drainage has on improving patient outcomes, and the role this unique solution plays in enabling that achievement,” stated Louis Perrault, MD, Ph.D., Chief of Cardiac Surgery at the Montreal Heart Institute, Montreal, Canada. “These findings, together with our randomized control trial, and several other groups’ studies, describe a compelling solution for improving patient care.”
“We appreciate the opportunity to work globally with clinical teams in enabling enhanced recovery for cardiac surgery patients,” said Paul Molloy, President and CEO of ClearFlow. “It is gratifying to see yet another addition to the substantial body of peer-reviewed and published evidence, including a randomized controlled trial that achieved similar benefits, further demonstrating the quality of care gains associated with application of the PleuraFlow ACT System. The data again shows that by more effectively avoiding chest tube occlusion following cardiac surgery, there is a profound and statistically significant reduction in reinterventions for complications caused by retained blood. We look forward to continuing to support healthcare providers engaged in ERAS Cardiac and cardiac surgery outcomes improvement initiatives.”
About ClearFlow, Inc. and PleuraFlow® Active Clearance Technology (ACT)
PleuraFlow® ACT 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 pleural effusions, pericardial effusions and post-operative atrial fibrillation (POAF).
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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