Lombard Introduces Aorfix EVAR Stent Graft in United States
August 27, 2013—Lombard Medical Technologies PLC (Oxfordshire, UK) announced the United States commercial launch of the company’s Aorfix flexible stent graft for the endovascular repair of abdominal aortic aneurysms (AAA).
The US Food and Drug Administration approved Aorfix in February 2013. The approval included a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0º to 90º. Additionally, the Aorfix endovascular stent graft has approved labeling for use in more challenging cases with neck angulations greater than 60º.
According to the company, the Aorfix device has been used successfully to treat the first patients in the United States. These initial cases included patients with aortic neck angles significantly greater than 60º. The company noted that these cases would have previously required open surgical AAA repair or off-label use of an alternative device not designed to treat patients with this level of tortuosity in the aorta.
Victor J. Weiss, MD, of Meriter Hospital in Madison, Wisconsin, and Sachinder Hans, MD, of Henry Ford Hospital in Detroit, Michigan, conducted the first cases in the United States with the Aorfix stent graft.
In Lombard’s press release, Dr. Weiss commented, “The flexible design of Aorfix promises to make it possible to treat the most challenging patients and provides a less invasive treatment option to open surgery repair. Based on my initial experience with Aorfix, I believe its ease of use and unique design will provide us with an important new tool to ensure the effectiveness of endovascular treatment of AAAs.”
Dr. Hans added, “I was particularly impressed by how Aorfix conformed to a very challenging anatomy. This patient had several health issues that existed prior to the procedure, including poor renal function and heavy calcium deposits, but we had a very successful outcome due to our ability to address the AAA in a minimally invasive fashion. Aorfix provides a new and important addition to the armamentarium of physicians working with patients with AAAs.”