Lombard Medical has partnered with the Society for Vascular Surgery Patient Safety Organization (SVS PSO) and M2S to develop a FDA-required post-marketing surveillance programme for Aorfix, an endovascular stent graft to treat abdominal aortic aneurysms (AAA).
Lombard Medical will use the Vascular Quality Initiative (VQI) Endovascular AAA Registry, the PATHWAYS cloud-based data platform and M2S Preview 3D modelling to track outcomes in patients treated with Aorfix at up to 50 VQI centres nationwide. Aorfix has been used to treat more than 3,000 patients worldwide since it first received regulatory approval. The FDA requires post-market surveillance of any device intended to be implanted in the body for more than a year.
The surveillance programme will consist of reporting from multiple centres on a non-randomised basis. Freedom from aneurysm-related mortality will be assessed at five years following the initial procedure in approximately 234 patients.
Jack L Cronenwett, medical director for the Society for Vascular Surgery Patient Safety Organization, states, “We have been working with Lombard Medical, M2S and the FDA to construct a post-approval surveillance programme which integrates clinical registry data on patient outcomes after endovascular abdominal aortic aneurysm repair with 3D CT scan imaging for detailed device monitoring. This quality improvement initiative will collect data and follow-up time points for patients in VQI and analyse these data along with image data for quality improvement purposes within the SVS PSO. In addition, non-identifiable data from this project will be shared with the FDA and Lombard Medical to satisfy post-approval surveillance requirements.”
Lombard Medical CEO Simon Hubbert said, “We could not have chosen better partners to collaborate with on this post-market surveillance programme, and we are extremely confident that Aorfix will continue to show superior clinical results in both challenging ‘high neck angle’ anatomy and more easily treatable aneurysm patients. We look forward to working with SVS and M2S in support of this post-market surveillance programme.
Gregory Lange, president and CEO of M2S, added, “By combining the VQI clinical quality data and quantitative anatomic information from M2S’ Preview imaging services, Lombard Medical and the FDA will have a complete picture of the patients being treated, their anatomy, the performance of Lombard’s graft and the clinical outcomes. This is a significant development in the monitoring of endovascular aortic aneurysm performance post-approval.”
The Vascular Quality Initiative
The Vascular Quality Initiative is a distributed network of regional groups that use the Society for Vascular Surgery Patient Safety Organization and the M2S cloud based system to collect and analyse data to improve the quality of vascular health care. Through regional quality group meetings, VQI participants share data to develop quality improvement projects designed to standardize processes, improve outcomes, and reduce complications and costs. Currently the VQI includes 11 registries including the Endovascular AAA Registry.