News | Cardiovascular Surgery | September 08, 2017

ClearFlow Inc. Announces Positive U.S. Clinical Trial Results

Reduction of hospital complications and resource utilization after heart surgery demonstrated with use of the PleuraFlow ACT System

ClearFlow Inc. Announces Positive U.S. Clinical Trial Results

September 8, 2017 — ClearFlow Inc. announced recently that positive clinical trial results were presented at the International Coronary Congress (ICC) 2017 annual meeting, Aug. 18-20 in New York City. The findings were presented by the study principal investigator Yvon Baribeau, M.D., FACS, of Catholic Medical Center in Manchester, N.H., in a presentation titled “Active Clearance of Chest Drains Reduces Retained Blood and ICU Resources after Off-Pump Coronary Artery Bypass Surgery.”

This data stems from a trial evaluating the use of the PleuraFlow Active Clearance Technology (ACT) System to prevent retained blood complications in heart surgery patients. PleuraFlow is a medical device used at the bedside in the ICU that enables caregivers to proactively maintain chest tube patency following cardiac surgery.

The primary endpoint of this study was reduction in the composite of retained blood syndrome, which includes any of the following interventions performed during index hospitalization and 30-days readmission: re-exploration for bleeding, delayed sternal closure, and pleural and pericardial interventions. The results demonstrated a statistically significant reduction of interventions for retained blood syndrome by 60.4 percent in the treatment group, including a 70 percent reduction in thoracentesis, a 33.7 percent reduction of postoperative atrial fibrillation (POAF) and a 65.6 percent reduction in infections. As seen in prior clinical trials, patients treated with the PleuraFlow System also had a statistically significant reduction in their overall hospital length of stay (LOS) by 1 day.

The PleuraFlow Active Clearance Technology System is approved for use in the United States, Europe, Australia, Brazil, Canada, Mexico, and other countries in Asia and the Middle East.

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