U.S. FDA Approval Of Aorfix™

Main Category: Medical Devices / Diagnostics
Also Included In: Vascular;  Regulatory Affairs / Drug Approvals
Article Date: 19 Feb 2013 - 3:00 PST


Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, has announced that Aorfix™ has been approved for commercial sale in the U.S. by the U.S. Food and Drug Administration ("FDA"). Aorfix™ is the Company's flexible stent graft for the endovascular repair of abdominal aortic aneurysms ("AAAs"). Data from the U.S. PYTHAGORAS trial of Aorfix™, has demonstrated that Aorfix™ can successfully treat a larger patient population than competing devices, including both standard and difficult to treat cases of AAAs.

The U.S. approval for Aorfix™ includes a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Aorfix™ is now the only endovascular stent graft licensed in the U.S. for use in more challenging cases with neck angulations greater than 60 degrees. Independent market research suggests that the U.S. market for the repair of AAAs is worth over $600 million per annum(1), is forecast to grow at approximately 8%(1) per annum, and that up to 30% of all patients have some tortuosity either at the neck of the aneurysm or in the iliac arteries(2). It is to this segment of patients that Aorfix™ is targeted with its uniquely flexible design. In Europe Aorfix™ is already licensed to treat neck angulations of up to 90 degrees.

The PYTHAGORAS trial of Aorfix™ is the largest prospective controlled study, to date, of stent grafting in patients with highly angled aortas. 218 patients at risk of aneurysm rupture were recruited in the trial and included 151 patients with neck angles greater than 60 degrees and 67 patients with neck angles less than 60 degrees. No aneurysms expanded in patients with neck angles less than 60 degrees and just 1.8% expanded in the patients with high neck angles, comparing favourably with the results of other devices in normal, less tortuous anatomy.

CEO of Lombard Medical Technologies, Simon Hubbert, commented:
"FDA approval of Aorfix™ is a major milestone for the Company and sets the stage for the next chapter in the Company's growth. I would like to thank all of our employees, investigators and clinical advisors for their support and hard work, without which development and approval of Aorfix™ would not have been possible. Aorfix™ is now the only stent graft approved in the U.S. to treat AAAs with neck angulations up to 90 degrees, a key advantage over other currently available stent grafts. We look forward to launching Aorfix™ in the U.S. through our own sales force and are confident of securing a meaningful share of this growing market."

Dr Mark Fillinger of Dartmouth Hitchcock Medical Centre, New Hampshire (principal investigator for the Aorfix™ trial), commented:
"Having seen the benefits of using Aorfix™ in patients first hand, I am delighted such a device is now available to treat patients in the U.S. Aorfix™ allows a minimally invasive repair of complicated high-angle AAAs to be performed, addressing a clear unmet medical need. These patients would otherwise require relatively high risk and more expensive open heart surgery and many are not strong enough to undergo such a serious intervention."

• Additional
• References
• Citations