The data presented were from Lombard’s Retrospective Aorfix Data Retrieval (RADAR) voluntary registry for all Aorfix customers. Phillips said that the Aorfix device has been utilised in the largest series of patients with difficult and tortuous anatomy ever studied, yet still had outstanding clinical results, highlighted by a very low incidence of stent migration (0%), wire fracture (<0.25%) and graft limb occlusion (<0.25%) at 12 months in the data set of 461 eligible patients.
In the session attended by many of the leading vascular interventionalists in the country, Phillips also gave a brief update on recruitment into Lombard’s pivotal FDA study for Aorfix in which he stated that, to date, more than 175 patients had been recruited into the trial, and that the Company requires 160 patients with follow-up to 12 months for submission to the FDA (minimum 40 low angle and 120 high angle). The Company has now recruited patients in excess of the minima and is on track to have the required number of patients with appropriate follow-up completed during the first half of 2011.
