Business
FDA approval for device
FDA approval for device.
About this update from Surgical Innovations Group Plc
[{"type":"text","content":"\n RNS Number : 0340Q Surgical Innovations Group PLC 28 July 2010 \n \n\n\n\n\n\nFor immediate release \n\n\n28 July 2010\n\n\n\n\n \nSurgical Innovations Group plc\n(\"SI\" or \"the Group\")\nFDA Approval for Logi®Flex\n \nSurgical Innovations Group plc (AIM:SUN), the designer and manufacturer of innovative medical devices, is pleased to announce that it is has received 510(k) clearance from the US Food and Drug Administration (\"FDA\") for its Logi®Flex device.\nThis clearance permits the use of Logi®Flex in the US market for both gastric band deployment and other associated bariatric procedures.\nLogi®Flex is a Resposable® articulating instrument which combines both reusable and disposable elements - the insert is single use and the handle is reusable - to offer surgeons a high quality and cost effective solution. \nThe device has a sterile insert which allows surgeons to fix gastric bands around the top of a patient's stomach. It also has a unique slot design which provides a positive grip on the suture allowing the band to be pulled into position with the minimum of inconvenience.\nIt is estimated that 250,000 anti-obesity procedures are performed annually in the US where obesity affects more than 60 million people, representing the second largest cause of preventable death. \n \nGraham Bowland, Chief Executive Officer of the Group, said: \"We are delighted to be able to announce this approval which will see the pioneering device now being sold into the US. The majority of surgical instruments in the US are single use; however with growing financial constraints being placed on hospital budgets, procurement managers are continuously looking for cost effective instrumentation and Logi®Flex offers the ideal high quality, cost effective solution.\"\n- Ends -\nEnquiries:\n\n\n\n\n\nSurgical Innovations Group plc\n\n\n \n\n\n\n\nDoug Liversidge, Non-Executive Chairman\n\n\nTel: +44 (0) 113 230 7597\n\n\n\n\n \n\n\n \n\n\n\n\nGraham Bowland, Chief Executive Officer\n\n\nTel: +44 (0) 113 230 7597\n\n\n\n\[email protected]\n\n\nwww.surginno.com\n\n\n\n\n \n\n\n\n\n\nWesthouse Securities Limited\n\n\n \n\n\n\n\nTim Feather / Matthew Johnson\n\n\nTel: +44 (0) 113 246 2610\n\n\n\n\[email protected] \n\n\nwww.westhousesecurities.co...