Business
Further Progress at RUA Vascular
Further Progress at RUA Vascular.
About this update from Rua Life Sciences Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 5686B\n RUA Life Sciences PLC\n 09 October 2020\n \n \n \n \n RUA Life Sciences plc\n \n \n (\"RUA\", the \"Company\" or the \"Group\")\n \n \n \n \n \n Further Progress at RUA Vascular\n \n \n RUA Life Sciences plc (AIM: RUA.L), the holding company of a group of medical device businesses focused on the exploitation of the world's leading long-term implantable biostable polymer (Elast-Eon\n ™\n ), is pleased to announce that its subsidiary RUA Vascular, which is developing Elast-Eon\n ™\n sealed vascular grafts and cardiac/vascular patches, has made further progress on both the regulatory and commercial pathways towards product launch.\n \n \n RUA Vascular - Product Development and Commercialisation\n \n \n As previously announced on 5 August 2020, RUA Vascular recently reached the important milestone of achieving design freeze on its vascular graft products. This allowed grafts to enter the regulatory testing phase in advance of 510k submission to the FDA. The 510k process, or \"Pre-Market Notification\", is a much simpler regulatory path than the more stringent \"Pre-Market Approval\" process and is available to medical devices that can claim \"Substantial Equivalence\" to legally marketed equivalent devices that are for the same intended use and have the same technology or different technology that does not raise new questions regarding safety or effectiveness. The RUA Vascular graft was designed with the 510k process in mind and the testing of the recently \"frozen\" design is to demonstrate this \"Substantial Equivalence\". RUA anticipates the 510k data package to be submitted early Q2 of 2021.\n \n \n An important part of this testing phase includes a long-term animal trial of both RUA's graft and the market leading graft as a control (the \"Substantial Equivalent\"). The RUA grafts have now been implanted without incident and the animals have recovered well. The graft has performed perfectly during surgical implant. Initial feedback given by the surgeons and confirmed by videos of the procedures was that the graft was simple to suture with no difference to the control graft. No or little bleeding from the anastomosis (or suture line) was observed with a suggestion that the elastomeric coating on the graft has assisted suture sealing. Importantly, the graft body maintained zero po...