Lombard Medical Technologies, a healthcare products manufacturer based in the United Kingdom, announced that it had received approval from the United States Food and Drug Administration for its Aorfix device. The Aorfix device is designed to treat abdominal aortic aneurysms in patients with abnormal or challenging neck anatomies.
In its press release, the company detailed the benefits of the Aorfix device. Unlike other stent grafts available on the market, the Aorfix can be used in patients with neck angulations ranging from 0 to 90 degrees. As of now, there are no other FDA-approved devices that can treat patient neck angulations over 60 degrees.
The aortic aneurysm market in the United States is worth an estimated $600 million. Current players include giants like W.L. Gore and Medtronic. While Lombard does have a unique product at the moment, it will face stiff competition from existing players.
Simon Hubbert is the CEO of Lumbard. In prepared remarks, he said, "Aorfix is now the only stent graft approved in the U.S. to treat AAAs with neck angulations up to 90 degrees, a key advantage over other currently available stent grafts. We look forward to launching Aorfix in the U.S. through our own sales force and are confident of securing a meaningful share of this growing market."
Lombard will use the new funds to expand production capacity and marketing initiatives for the device.