Endovascular Aneurysm Repair (EVAR) specialist Lombard Medical, Inc., has gained U.S. FDA approval for its Aorfix™Plus endovascular stent graft.
Aorfix received initial FDA clearance in February 2013 for proximal diameter devices between 24mm-31mm. Lombard Medical says the approval for this new addition to the Aorfix™ endovascular stent graft portfolio expands the range of proximal neck diameter sizes up to 36mm, potentially allowing up to 10% more patients with AAAs to be treated with the Aorfix platform.
Aorfix™ is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms (AAAs). When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. 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. It features an exclusive helical and circular design that allows it to conform to the natural contours of human anatomy, including aortic necks with high angulations and iliac arteries with extreme bends.
The company will begin rolling out this expanded range in the second quarter of 2015 with the launch of a 34mm AorfixPlus stent graft in the U.S.
“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.”
Source: Lombard Medical, Inc.