With FDA approval and $32M, Lombard eyes U.S. stent launch

The Aorfix stent, which uses the Aorflex delivery system.--Courtesy of Lombard Medical

Lombard Medical Technologies snagged U.S. regulatory approval for the delivery system used in its Aorfix stent, itself approved by the FDA in February. With the go-ahead on the delivery system, the company aims to start selling the stent in the U.S. by the end of this year.

The London devicemaker also raised £20.9 million ($32.1 million) and will use that funding, along with its existing £15.2 million ($23.3 million) in resources, to launch the stent in the U.S.

The delivery system, called Aorflex, was designed specifically for the Aorfix stent, which is used for the endovascular repair of abdominal aortic aneurysms, balloon-like growths of the aorta. The stent is the only device with neck angulations up to 90 degrees, according to the company. It has been available in Europe since April 2012 with positive clinical feedback, Lombard said.

And with the Aorflex delivery system, the device shows several improvements, including smoother introduction into the blood vessels, better deployment control, an X-ray marker for positional feedback and reduced deployment forces, according to the company.

"The approval of the accompanying Aorflex delivery system by the FDA is a tactically important achievement that will help ensure that clinicians deploy our stent graft most effectively," said Lombard CEO Simon Hubbert in a statement. "This in turn should increase clinician adoption of Aorfix as the stent graft of choice, especially in patients with (abdominal aortic aneurysms) that present with more challenging anatomies."

- here's the release

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