Lombard’s Aorfix Plus stent graft to hit the market

Lombard Medical has received FDA for its ‘Aorfix Plus’ endovascular stent graft.

The approval expands the group’s range of proximal neck diameter sizes up to 36mm, potentially allowing up to 10% more patients with abdominal aortic aneurysm (AAAs) to be treated with the Aorfix platform.

Lombard Medical will begin rolling out this expanded range in the second quarter of 2015 with the launch of a 34mm AorfixPlus stent graft.

Aorfix is the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees, often a feature of complicated AAA anatomies.

"Patients with AAAs present with a wide range of anatomies that vary based on age, gender and other factors, so the availability of an assortment of stent graft sizes is a key factor in selecting the right device for your patient," said Dr. Nilo Mosquera, M.D., Vascular Surgeon, University of Ouresne Hospital, Spain. "Combining its unique flexibility, its comprehensive sizing options and ability to treat patients with highly angulated necks, Aorfix allows physicians to address the needs of a diverse patient population."

"The approval of AorfixPlus further expands our ability to treat a wide range of patient anatomies, including highly-angled necks and large neck diameters," said Simon Hubbert, CEO of Lombard Medical. "Our aim is to provide the most effective on-label solution for the broadest AAA patient population - this clearance gets us closer to that goal. Aorfix's unique indication to treat patients with aortic neck angulations up to 90 degrees, coupled with a comprehensive suite of sizing options, will allow an even greater number of patients with AAAs to benefit from treatment with Aorfix."

Aorfix received initial FDA clearance in February 2013 for proximal diameter devices between 24mm-31mm. This new FDA approval now provides the ability for the company to market Aorfix devices between 24mm-36mm in the U.S.