Lombard Medical Technologies (NSDQ:EVAR) said it won clearance from the FDA for its Aorfix Plus device, a stent graft designed to treat larger-size abdominal aortic aneurysms.Irvine, Calif.-based Lombard said the PMA nod is for treatment of aneurysms with proximal neck diameter sizes of up to 36mm. The company plans to roll out the AorfixPlus on the U.S. market during the 2nd quarter, according to a press release.
“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,” Dr. Nilo Mosquera of Spain’s University of Ouresne Hospital said in prepared remarks. “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,” added Lombard CEO Simon Hubbert. “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°, coupled with a comprehensive suite of sizing options, will allow an even greater number of patients with AAAs to benefit from treatment with Aorfix.”
Lombard 1st won U.S. approval for Aorfix in February 2013. The company raised $55 million in an initial public offering in April 2013.
