FDA expands label indication for PleuraFlow to reduce retained blood


The US Food and Drug Administration (FDA) has granted expanded indications for use of ClearFlow’s patented PleuraFlow Active Clearance Technology system. PleuraFlow is a patented medical device that prevents chest drains from occluding with clot, which can lead to retained blood around the heart and lungs.

The composite of drainage related complications that are detrimental to outcomes after cardiothoracic surgery and that may require early or late intervention to remediate are known as retained blood syndrome. These clinical complications have significant economic consequences, namely higher costs of care for patients, hospitals, and society at large.

“A recently published study showed chest drains completely occlude at a rate of 36%,” commented ClearFlow chief executive officer Paul Molloy. “Physicians are forced to gamble that the chest drains will stay open during the critical first hours after heart surgery. Retained blood syndrome leads to high rates of post-surgical complications that drive increased costs and 30-day hospital readmissions. The PleuraFlow Active Clearance Technology system is the first FDA cleared device indicated to maintain chest drain patency and to reduce retained blood. Retained blood syndrome is associated with higher rates of mortality, post-operative atrial fibrillation, renal dialysis, stroke, infection and extended intensive care unit and total hospital length of stay after cardiothoracic surgery. PleuraFlow has been shown to reduce the incidence of retained blood as well as other complications such as POAF by keeping chest tubes free of occlusion during early recovery.”

The FDA’s expanded indications for use also allow the PleuraFlow system to be used in all cardiothoracic surgery and chest trauma procedures for adult and paediatric patients.

“For decades, surgeons have worked to reduce the complication rates associated with inadequate drainage of blood around the heart and lungs after surgery,” remarked cardiothoracic surgeon and ClearFlow co-founder Ed Boyle. “This unevacuated blood can be mechanically detrimental to heart and lung function and causes both local and systemic inflammation that impact recovery. Studies have now linked both chest tube clogging and retained pericardial blood with post-operative atrial fibrillation. We are delighted that the FDA has evaluated data demonstrating that PleuraFlow reduces retained blood and has granted these expanded indications for use. This is an additional step forward towards the establishment of new standard of care for post-surgical chest tube patency in the ICU.”