ClearFlow reports positive PRO-ACT trial results of PleuraFlow system

12 October 2014 (Last Updated October 12th, 2014 18:30)

US-based medical device firm ClearFlow has reported positive results from the Prevention of Retained Blood Outcomes Using Active Clearance Technology trial, (PRO-ACT), a clinical trial evaluating the use of PleuraFlow System to prevent retained blood complications.

US-based medical device firm ClearFlow has reported positive results from the Prevention of Retained Blood Outcomes Using Active Clearance Technology trial (PRO-ACT) a clinical trial evaluating the use of PleuraFlow System to prevent retained blood complications.

The PleuraFlow system allows caregivers to actively keep chest drainage tubes clear of clots immediately after heart surgery.

The trial evaluated the efficacy of the protocol for actively clearing chest tubes of clotted blood to prevent retained blood complications.

A primary outcome of the trial included less interventions for retained blood complications after heart surgery and prior to discharge.

"The PleuraFlow system allows caregivers to actively keep chest drainage tubes clear of clots immediately after heart surgery."

ClearFlow founder and chairman Ed Boyle said: "Chest tube clogging is known to occur in over one-third of heart surgery patients in the early hours after heart surgery, and nearly one in five can have some form of retained blood complication that includes the need to perform subsequent invasive reinterventions to remove undrained blood or clots from inside the chest after heart surgery."

Klinikum Nürnberg Heart Center study principal investigator Dr Theodor Fischlein has presented the results at the Cardiovascular-Thoracic (CVT) Critical Care 2014 annual meeting. The meeting was organised by the Foundation for the Advancement of CardioThoracic Surgical Care (FACTS-Care) in Washington, DC.

The results showed a significant reduction of interventions for retained blood complications by 42% in the treatment group and also of postoperative atrial fibrillation (POAF).

According to the company, patients treated with PleuraFlow System had a statistically significant reduction in bleeding, suggesting that the Active Clearance Technology may help reduce the amount of bleeding following heart surgery.

The company's PleuraFlow System with Active Clearance Technology is approved for use in the US, Europe, Australia, Brazil and Canada.

The system has either been cleared or is pending clearance in other countries.