Lombard Medical Engages SVS and M2S for Postmarket Surveillance of Aorfix

September 24, 2014—Lombard Medical announced that it has partnered with the Society for Vascular Surgery Patient Safety Organization (SVS PSO) and M2S Inc. to develop a US Food and Drug Administration- (FDA-) required postmarketing surveillance program for the company’s Aorfix endovascular stent graft, which is used to treat abdominal aortic aneurysm (AAA).

Lombard Medical will use the Vascular Quality Initiative (VQI) Endovascular AAA Registry, the Pathways cloud-based data platform, and M2S Preview 3D modeling to track outcomes in patients treated with Aorfix at up to 50 VQI centers nationwide.

The surveillance program will consist of reporting from multiple centers on a nonrandomized basis. Freedom from aneurysm-related mortality will be assessed at 5 years after the initial procedure in approximately 234 patients. The FDA requires postmarket surveillance of any device intended to be implanted in the body for more than 1 year, noted the company.

Lombard’s Aorfix was first introduced in Europe for the treatment of AAAs with angulation at the neck of the aneurysm of up to 90º. It was approved in the United States in February 2013 and in Japan in August 2014.

In Lombard Medical’s press release, SVS PSO Medical Director Jack L. Cronenwett, MD, commented, “We have been working with Lombard Medical, M2S, and the FDA to construct a postapproval surveillance program which integrates clinical registry data on patient outcomes after endovascular AAA 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 analyze these data along with image data for quality improvement purposes within the SVS PSO. In addition, nonidentifiable data from this project will be shared with the FDA and Lombard Medical to satisfy postapproval surveillance requirements.”

According to Lombard Medical, the VQI is a distributed network of regional groups that use the SVS PSO and the M2S cloud-based system to collect and analyze 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. The VQI is built on the M2S Pathways clinical data performance platform, which allows users to track, measure, and analyze clinical information; promote collaboration; objectively drive decisions; and optimize performance.

The goal of the SVS PSO is to improve patient safety and the quality of vascular health care delivery by providing web-based collection, aggregation, and analysis of clinical data submitted in registry format for patients undergoing specific vascular treatments through the use of the M2S Pathways cloud-based data platform. The SVS PSO provides outcome analysis intended to be an integral component of each participating health care provider's quality improvement efforts, including the implementation of recommendations, protocols, and best practices by the SVS PSO.