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US FDA 510(k) Clearance for AQUACELT Ag Advantage
US FDA 510(k) Clearance for AQUACELT Ag Advantage.
About this update from Convatec Group Plc
[{"type":"text","content":"\n \nRNS Number : 5091V ConvaTec Group PLC 24 July 2018 \n\n \nConvaTec Receives U.S. FDA 510(k) Clearance for its most advanced and innovative antimicrobial dressing: AQUACEL™ Ag Advantage dressing\n \n· Developed to help clinicians reduce the significant burden of chronic, non-healing wounds\n· Unique Advantage formulation provides enhanced antimicrobial performance[1] in combination with Hydrofiber™ Technology\n \nREADING, UNITED KINGDOM (24 July 2018) - ConvaTec Group Plc (\"ConvaTec\"), a leading global medical products and technologies company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its AQUACEL™ Ag Advantage* dressing for wound management. \n \nIn clinical studies and global practice, ConvaTec's proven, advanced antimicrobial dressing has demonstrated substantial wound improvements even in the most hard-to-heal wounds[2],[3], and in 2016 was recognized by international wound care experts for its innovative and breakthrough technology with the ability to change patient lives. \n \nChronic non-healing wounds have a significant impact on quality of life for patients, many of whom are elderly, have diabetes or other underlying conditions, which often lead to serious events such as limb amputations or premature death.[4] In the U.S. Medicare recently published data showed that 8.2 million seniors had at least one type of wound or wound-related infection, with an estimated annual cost of up to $96.8 billion.[5] \n \n\"Delayed wound healing presents multiple challenges for clinicians, and places a heavy burden on patients, society and our healthcare systems. Moving these types of recalcitrant wounds from a deteriorating or stagnant state toward improvement requires novel, non-antibiotic strategies,\" said Randall Wolcott, MD, Medical Director, Southwest Regional Wound Care Center, Lubbock, Texas. \"I'm very excited about this new innovative dressing, which has shown significant potential to address this burden while not driving antibiotic resistance.\"\n \n\"AQUACEL Ag Advantage dressing is the culmination of many years of research and collaboration with clinicians to more effectively address their most difficult and persistent challenges in wound management,\" added Fi...