ClearFlow has announced positive clinical trial results of its PleuraFlow device, which were presented at the American Association for Thoracic Surgery (AATS) 99th Annual meeting on May 4 in Toronto, Canada.
This new data stems from a trial evaluating the use of ClearFlow’s PleuraFlow Active Clearance Technology (ACT) System in heart surgery patients at the Montreal Heart Institute.
PleuraFlow is a medical device used at the bedside in the ICU that enables caregivers to actively maintain chest tube patency following cardiac surgery. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. Retained blood is accepted by physicians as contributing to many common complications after surgery, including post-operative atrial fibrillation (POAF), pleural effusions and pericardial effusions. This prospective randomized controlled clinical trial, presented at AATS by Dr. Samuel St-Onge, demonstrated a statistically significant reduction in chest tube clogging and emergency reoperations for retained blood, and a directional reduction in POAF.
“This positive randomized clinical trial comes on the heels of five prior studies demonstrating that active maintenance of chest tube patency after cardiac surgery reduces complications related to retained blood,” said Dr. Edward Boyle, a cardiothoracic surgeon, and ClearFlow founder. “This study shows once again that the PleuraFlow system achieves a more efficient evacuation of shed mediastinal blood, which is critical in recovery after cardiac surgery.”
Also at this year’s AATS, an international group of leading heart surgeons, anesthesiologists and critical care specialists known as ERAS Cardiac Surgery, published the first “Guidelines for Perioperative Care: Enhanced Recovery After Surgery Society Recommendations.” These guidelines are published in the current edition of JAMA Surgery. In its guidelines, ERAS Cardiac Surgery recommends maintaining chest tube patency without breaking the sterile field to prevent retained blood complications as a Class I, Level B-NR classification. These recommendations were also endorsed by the Enhanced Recovery After Surgery (ERAS) Society.
“ERAS’ new guidelines published in JAMA Surgery combined with successful randomized trial results represent clear validation that active clearance of chest tubes following heart surgery reduces clinical complications of retained blood and reduces hospital resource utilization and costs related to treating complications,” said Paul Molloy, CEO of ClearFlow. “The PleuraFlow System is the only device on the market shown to proactively prevent chest tube clogging and retained blood during early recovery in heart surgery patients.”
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.
Source: Company Press Release