The first-in-man clinical EVAR case using Lombard’s new IntelliFlex LP delivery system to deploy its Aorfix endovascular stent graft has produced successful outcomes.
According to Lombard, the IntelliFlex LP Delivery System is designed to be low profile, intuitive, compact and ergonomic, enhancing the precision and control of Aorfix deployment and placement. The system incorporates an integrated exchange sheath designed to reduce the possibility of vessel trauma during the procedure.
The case was performed by the team of Andrew Holden, director of interventional services and associate professor of radiology at Auckland University School of Medicine, and Andrew Hill, professor of surgery, University of Auckland, at Auckland City Hospital, New Zealand.
“The new IntelliFlex delivery system was extremely straightforward and a real pleasure to use,” says Holden. “I particularly appreciated the new Y-mechanism that enables greater control and precision when deploying the graft. This is a significant advancement for the Aorfix system and the device can now be used even more reliably in both routine and challenging anatomies.”
Hill adds, “The new Aorfix delivery system has great top end control allowing for very accurate placement of the device. Further, the integrated exchange sheath was really beneficial and the haemostatic valve copes extremely well with multiple passages.”
CEO Simon Hubbert says, “We plan to file for FDA approval in early December and anticipate launching in the USA in the early second quarter of 2016, followed by EU approval and launch one quarter later.”