CE Mark for CleanCision wound retraction and protection system.- Prescient Surgical,

Prescient Surgical announced it received CE Mark approval for its first-in-class, advanced technology CleanCision which fights and defends against the sources of surgical site infection (SSI). With CE Mark approval, CleanCision is now available to European hospital systems who are also facing higher than average surgical site infection rates in colorectal and other abdominal surgeries, nearly 27% according to a U.K. surveillance study. CleanCision received FDA 510(k) clearance in the United States in October, 2017.

CleanCision also received ISO 134385:2016 certification of its quality management system following completion of an audit by LNE/G-MED, the international body governing quality in medical device manufacturing. This certification demonstrates the company�s focus on quality and demonstrates its ability to provide medical devices that consistently meet both customer and applicable regulatory requirements. The approval means that the system is now available to European hospitals that face high rates of SSIs in colorectal and other abdominal surgeries.

Comment: Unlike traditional intraoperative methods, which cannot continuously and consistently clear contamination from the surgical site, CleanCision combines wound protection and irrigation into an advanced, intuitive, and easy-to-use retraction system that actively, consistently, and continuously clears harmful bacteria that invades the incision during surgery.