Lombard Medical Technologies, plc has seen a first U.S. patient treated with its Aorfix™ endovascular stent graft for repair of an abdominal aortic aneurysm. Aorfix is the only endovascular stent graft with approved labeling for use in more challenging cases with neck angulations greater than 60 degrees.
We last covered Lombard Medical Technologies back in February of this year when it was announced that the company’s Aorfix™ endovascular stent graft had gained FDA approval. The Aorfix approval included a label indication for thetreatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. This makes Aorfix the only endovascular stent graft with approved labeling for use in more challenging cases with neck angulations greater than 60 degrees.
The first U.S. cases using Aorfix included patients with aortic neck angles significantly greater than 60 degrees that would have previously required more invasive 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. The patients were treated by Victor J. Weiss, M.D., a vascular surgeon at Meriter Hospital in Madison, WI and Sachinder Hans, M.D. of Henry Ford Hospital in Detroit, respectively.
Dr. Victor 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. Sachinder 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.”
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 U.S. 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 AAA market in the United States.”
Source: Lombard Medical plc., Market Wire