ClearFlow Announces Positive Results from its PleuraFlow System Trial
Anaheim, Calif., devicemaker ClearFlow announced positive results from its PRO-ACT trial assessing the use of the company’s PleuraFlow system to prevent retained blood complications. The system allows healthcare givers to keep chest drainage tubes free of clots immediately after heart surgery.
The PRO-ACT trial — Prevention of Retained Blood Outcomes Using Active Clearance Technology — looked at the system’s efficacy in actively clearing chest tubes of clotted blood to prevent complications. The primary outcome was a reduction of interventions for retained blood complications following heart surgery and before the patient’s discharge.
Patients who received the treatment saw the number of required interventions reduced by 42 percent, ClearFlow said. The amount of bleeding was also reduced.
The initial purpose of the trial was to evaluate the occurrence of retained blood complications in a large data set from a single German center, ClearFlow spokeswoman Kelly Herman told Device Daily Bulletin. The study’s primary outcome was to see if there was a reduction in baseline retained blood complications prior to discharge after surgery with use of the device, she added.
According to company, chest tube clogging occurs in over a third of heart surgery patients in the hours following surgery. One in five patients have some form of retained blood that results in invasive reinterventions to remove the undrained blood or clots from inside the chest. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.