Postmarketing Surveillance Program Begins for Lombard Medical's Aorfix EVAR Device

April 15, 2015—Lombard Medical, Inc. announced the successful enrollment of the first patients in its postmarketing surveillance program for the company’s Aorfix endovascular stent graft, which has global approvals for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) patients with aortic neck angulations up to 90º. The surveillance program is designed to assess freedom from aneurysm-related mortality at 5 years after AAA treatment with Aorfix and plans to enroll 234 patients. Results will be collected on a nonrandomized basis from up to 50 enrolled centers in the United States.

Lombard Medical noted that it has partnered with the Vascular Quality Initiative (VQI) Endovascular AAA registry, M2S’s Pathways cloud-based data platform, and M2S Preview three-dimensional modeling to track outcomes in patients treated with Aorfix at VQI centers nationwide. 

The VQI 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 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 is composed of 12 registries including the VQI Endovascular AAA registry. In addition to clinical registries, M2S serves as a core lab for postapproval surveillance projects.