News | Cardiovascular Surgery | June 19, 2015

FDA Expands Label Indication for PleuraFlow to Reduce Retained Blood

Device now indicated for retained blood syndrome, all cardiothoracic surgery and chest trauma procedures for adults and pediatrics

ClearFlow, PleuraFlow, FDA, expanded Indications for Use

June 19, 2015 - ClearFlow Inc. announced that the U.S. Food & Drug Administration (FDA) has granted expanded Indications for Use of the company's patented PleuraFlow Active Clearance Technology system. The PleuraFlow system 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 (RBS). 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 percent," commented ClearFlow CEO 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 indicated to maintain chest drain patency and to reduce retained blood. RBS is associated with higher rates of mortality, post-operative atrial fibrillation (POAF), renal dialysis, stroke, infection and extended ICU and total hospital length of stay after cardiothoracic surgery. The PleuraFlow system 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 pediatric 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, M.D. "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 POAF."

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