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Lombard Medical Technologies says first US Aorfix treatments go well


Lombard Medical Technologies (LON:LMT) revealed the first US patients have been successfully treated with Aorfix, its flexible stent graft used to treat ruptures to the main artery.

Aorfix was approved by the US Food & Drug Administration (FDA) for commercial sale in the US in February 2013, prompting 30% spike in the share price at the time for a stock that had already doubled in price over the previous year.

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 (AAA) repair or "off label" use of an alternative device not designed to treat patients with this level of tortuosity in the aorta.

All patients are doing well following the procedures.

Simon Hubbert, chief executive officer of Lombard Medical 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 Victor Weiss, a vascular surgeon who performed some of the operations, said: “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, MD of Henry Ford Hospital in Detroit, said: "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."

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