UK-based Lombard Medical Technologies (LMT) has successfully treated the first US patients with Aorfix, a flexible stent graft used for endovascular repair of abdominal aortic aneurysms (AAAs).
In February 2013, the Aorfix was approved for sale by the Food and Drug Administration (FDA) in US for treating patients with angulations at the neck of the aneurysms ranging from 0°-90°.
The first successfully treated US cases using Aorfix included patients with aortic neck angles greater than 60°.
The Aorfix replaces the previously used invasive open surgical AAA repair or alternative devices that were not licensed to treat patients with high aortic neck angles.
Meriter Hospital vascular surgeon Dr Victor Weiss, Henry Ford Hospital's Dr Sachinder Hans and Southern Illinois University School of Medicine vascular surgery division's Dr Kim Hodgson reported success in the treatment of patients with aortic neck angles significantly greater than 60° using Aorfix.
LMT CEO Simon Hubbert said they 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," Hubbert said. "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 AAA market in the United States."
Dr Weiss said 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 Weiss said.
Dr Hans added: "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."