The FDA win gives Lombard permission to market the Aorfix device in treatment of challenging neck angulations from the range of 0 to 90 degrees. No other devices are indicated by the FDA to treat angulations over 60 degrees, according to the company.
"FDA approval of Aorfix is a major milestone for the company and sets the stage for the next chapter in the company’s growth," Lombard CEO Simon Hubbert said in prepared remarks. "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."
The FDA win represents an additional boon for Lombard, which can collect nearly $21.9 million (£14.1M) as part of a the 2nd half of a 2-tranche financing announced in 2011.
Lombard plans to use the new funds to launch U.S. Aorfix sales through a direct sales team and expand production capacity to meet the demand it anticipates for the product. Lombard will also use the funding to complete work on a larger range of stent graft sizes and to develop a next-generation Aorfix system with a lower profile, according to a press release.
The regulatory approval also triggered Lombard’s ability to half of a $5 million loan facility granted by Medico’s Hirata Inc., an exclusive distribution partner in Japan.