California’s Lombard Medical Technologies (NSDQ:EVAR) said it launched a post-market surveillance study of its Aorfix stent graft for abdominal aortic aneurysms, with plans to eventually enroll 234 patients.
The Irvine-based company said it signed up the 1st patients in the 5-year trial, which is designed to assess the mortality rate from aneurysm-related complications in patients treated with the Aorfix device.
Aorfix is an endovascular stent graft for AAA patients with aortic neck angulations of up to 90°, often a physiological feature in patients with "complicated anatomies," Lombard said.
Lombard is already moving ahead with next-generation versions of Aorfix and continues to eye international markets for its stent and the delivery system that goes with it. In February, it won the FDA’s OK for AorfixPlus, a stent graft designed to treat larger-size abdominal aortic aneurysms with proximal neck diameter sizes of up to 36mm. Lombard won Japanese regulatory approval in March for the AorFlex delivery system used to implant Aorfix.
For the post-market study, Lombard said it plans to partner with the Vascular Quality Initiative Endovascular AAA Registry, the Pathways cloud-base data platform and M2S Preview 3D Modeling to track outcomes in patients treated with Aorfix at VQI centers around the country.
