On 27 August 2013, Lombard Medical announced that the first US patients have been successfully treated with Aorfix, the company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms.
Aorfix was approved by the FDA for commercial sale in the USA in February 2013. The approval included a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Moreover, Aorfix is the only endovascular stent graft with approved labelling for use in more challenging cases with neck angulations greater than 60 degrees.
The first US cases using Aorfix included patients with aortic neck angles significantly greater than 60 degrees that would have previously required more invasive open surgical abdominal aortic aneurysm repair or “off label” use of an alternative device not designed to treat patients with this level of tortuosity in the aorta. The patients were treated by Victor J Weiss, a vascular surgeon at Meriter Hospital in Madison, and Sachinder Hans, of Henry Ford Hospital in Detroit, respectively. Kim Hodgson, of Southern Illinois University School of Medicine, Division of Vascular Surgery, Springfield, also reported a further case where the patient was successfully treated using Aorfix. All patients are doing well following the procedures.
Simon Hubbert, chief executive officer of Lombard Medical said: “We are delighted to see the first patients being treated with Aorfix since the FDA granted approval earlier this year. Previously these patients would have received more invasive open surgery repair or would have been treated using a less flexible endovascular device, unlicensed to treat high aortic neck angles. Since receiving US FDA approval, the company has invested in the right people and worked diligently to ensure we have the commercial infrastructure and processes in place to become a significant player in the abdominal aortic aneurysm market in the United States.”
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 abdominal aortic aneurysms.”
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 abdominal aortic aneurysm in a minimally invasive fashion. Aorfix provides a new and important addition to the armamentarium of physicians working with patients with abdominal aortic aneurysms.”