The 1st U.S. patients have been successfully treated with Lombard Medical Technologies (LON:LMT) Aorfix flexible aortic stent graft for the endovascular repair of abdominal aortic aneurysms, the company announced this week.
Aorfix gained FDA marketing approval in the U.S. in February with indication for use in patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Lombard touts it product as the only endovascular stent graft approved for use in more challenging neck angulations greater than 60 degrees.
“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," Lombard CEO Simon Hubbert said in prepared remarks.
AAAs are balloon-like enlargements of the aorta which can rupture and cause death if not treated, the Oxfordshire, England-based firm noted. Aortic aneurysm disease is among the leading causes of death in the U.S. and 1.7 million people over the age of 55 are estimated to have an AAA, representing a U.S. market value for AAA repair of more than $600 million annually, Lombard said. Around 4.5 million people in the developed world have AAAs and 600,000 new cases are diagnosed each year, and the global AAA repair market is forecast to grow to $1.6 billion by 2015.
The 1st U.S. Aorfix patients included some cases with aortic neck angles significantly greater than 60 degrees, who would have otherwise needed more invasive open surgical AAA repair or off-label use of an alternative device not designed to treat patients with this level of angulation in the aorta, Lombard 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,” Dr. Victor Weiss, a vascular surgeon at Meriter Hospital in Madison, Wisc., who was among the 1st to use the device, said on behalf of the company. “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."