Lombard Medical Technologies, the specialist medical device company, has announced that it has received European approval to extend its existing indication to treat abdominal aortic aneurysms (AAAs) with neck angulations up to and including 90° (currently 65°). This unique indication extends the use of endovascular treatment to patients with challenging anatomy that are often at risk in open surgical procedures due to their age or co-morbidities.
Brian Howlett, CEO of Lombard Medical, commented: “This significant additional indication extends the use of endovascular repair of abdominal aortic aneurysms to a group of patients who may not have any other treatment options. Furthermore, it demonstrates the versatility of Aorfix™ in treating a broad spectrum of patients and achieving good clinical outcomes, regardless of tortuosity of the vascular anatomy.”
The approval was received from Technischer Überwachungsverein (TÜV), Lombard Medical’s designated regulatory notified body, and follows submission of clinical data from a study to assess Aorfix in the treatment of AAAs with infrarenal neck angulations of between 60° and 90°. The technical results submitted demonstrated that Aorfix had a low occurrence of device deployment events and that the placement of the device in AAAs with high-angled infrarenal necks was well tolerated. Initial performance, as measured by the incidence of endoleaks at 30 days, was superior to that of the comparator historical data set.
For patients who had their 30-day and six-month follow-ups, there were no reports of device rupture, migration, stent fracture, loss of patency, vessel perforation, significant obstruction or conversion to open repair. Furthermore, all patients reviewed after six months were found to have a stable or shrinking aneurysm sac, indicating that the aneurysm was under control. The study report concluded that Aorfix in the treatment of high-angle-neck aneurysms was safe and effective in the short term.