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ConvaTec Receives FDA 510(k) Clearance for Avelle
ConvaTec Receives FDA 510(k) Clearance for Avelle.
About this update from Convatec Group Plc
[{"type":"text","content":"\n \nRNS Number : 3287F ConvaTec Group PLC 26 October 2018 \n\n \nConvaTec Receives U.S. FDA 510(k) Clearance for Avelle™ Negative Pressure Wound Therapy System\n \n· First and only system to combine Negative Pressure with the benefits of Hydrofiber® Technology\n· Lightweight, disposable system offers extended usage up to 30 days, suitable across different care settings \n \nREADING, UNITED KINGDOM (26 October 2018) - ConvaTec Group Plc (\"ConvaTec\"), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Avelle™ Negative Pressure Wound Therapy (\"NPWT\") system. The novel system is ConvaTec's entry into the fast-growing disposable space of the $1.1B U.S. NPWT market[1].\n \nThe unique, disposable device combines negative pressure wound therapy with the benefits of Hydrofiber® Technology, and the pump can be used for up to 30 days*. ConvaTec's proprietary Hydrofiber Technology, which is also featured in the company's AQUACEL® line of advanced dressings, is designed to help create a beneficial moist wound environment for healing[2]. The Avelle system is the only product on the market to offer this combination of advanced wound care technologies.\n \nFor patients, the Avelle NPWT system is designed to be lightweight, portable and easy-to-use, helping to give them more mobility and resume their daily activities, both in and out of the home, whilst their wounds progress towards healing[3]. In addition, Hydrofiber Technology helps prevent periwound maceration[4]**, a potential complication associated with NPWT that can lead to delayed healing[5].\n \n\"We are very pleased to bring the benefits of the Avelle NPWT system to healthcare professionals and patients in the U.S., where demand for disposable single-use negative pressure devices is growing at double digit rates1,\" said Fiona Adam, Interim President, Advanced Wound Care, ConvaTec. \"Customer response in European markets has been very positive, with clinicians and patients noting the disposable system's ease of use as well as its suitability from hospital to home.\n \nAt ConvaTec, we are committed to providing our customers with further differentiated technologies and comp...