Gore to leverage VQI® for post approval study using M2S PATHWAYS platform

W.L. Gore and Associates to leverage the Vascular Quality Initiative® to meet post-approval study requirements using the M2S PATHWAYS™ data and analytics platform. Over 280 participating hospitals have contributed the results of over 136,000 procedures to the Society for Vascular Surgery’s Vascular Quality Initiative®
West Lebanon, NH Apr 29, 2013 – M2S Inc., a leader in software-as-a-service for clinical quality improvement, today announced a ground-breaking joint initiative with the Society for Vascular Surgery® Patient Safety Organization and two aortic stent manufacturers to meet post-approval studies (PAS) requirements in the treatment of type B aortic dissections. Aortic Dissections are a serious cardiovascular condition associated with high morbidity and mortality in which the upper segment of the body’s main artery has become torn along the innermost layer of the vessel wall. Gore and one other manufacturer will leverage the Vascular Quality Initiative® (VQI®), which is powered by the M2S PATHWAYS™ clinical data performance platform, a cloud-based quality improvement registry for data collection, reporting, and collaboration.
The Conformable GORE® TAG® Thoracic Endoprosthesis is an FDA approved device on the market in the US. Approval was recently broadened to include treatment of chronic and non- complicated dissection, with the provision that the efficacy of TEVAR treatment of descending aortic dissection would be more fully analyzed through post-market study. This observational study is expected to collect 200 acute and 200 chronic dissection procedures, with 5 year follow-up. The use of real-time clinical registry data from the VQI® will increase the efficiency of executing a post-approval study, while improving the ability to provide real-world feedback.
Dr. Jack L. Cronenwett, Medical Director for the Society for Vascular Surgery® Patient Safety Organization, states, “For the past year, representatives of the SVS PSO, FDA, industry, M2S and scientific advisors from surgical societies have met to discuss the value of using registry data to measure the safety and efficacy of TEVAR treatment of aortic dissection. Based on these discussions, the SVS PSO is pleased to announce this voluntary quality improvement initiative that will collect additional data and follow-up time points for patients in VQI® who are treated for acute or chronic descending thoracic aortic dissection. These data will be analyzed and used for quality improvement purposes within the SVS PSO, and non-identifiable data from this project will be shared with the FDA and device manufacturers, to meet the needs of their post approval study requirement.”
Gregory Lange, President and CEO of M2S, Inc., adds, “We are thrilled to collaborate with the SVS, FDA and industry to help evaluate the safety and efficacy of new devices in real-world practice. We expect this to be the first of many opportunities to support industry through the use of the M2S PATHWAYS platform and the VQI®, and to support our mutual goal of improvement in vascular health care.”