"Active Chest Tube Clearance Added to an Enhanced Recovery After Cardiac Surgery (ERAS) Program Improves Outcomes and Reduces Resource Utilization"

Adding PleuraFlow’s Active Chest Tube Clearance (ATC) to an ERAS cardiac surgery program reduced Retained Blood Syndrome by 41%, postoperative atrial fibrillation (POAF) by 17%, and ICU time by 30% in 684 patients compared to 650 controls, improving outcomes and resource utilization. (Gerdisch, et al, 2025)

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Regulatory Update

2010 was a big year for regulatory approvals. The company announced in Q3 that it had received European and Canadian Regulatory approval, and in December, the company was granted a Class II FDA 510(k) clearance to allow us to market our device in the US as well. The difficult regulatory environment was a hot topic in the medical device industry in 2010 and this represents a major milestone for the company.