FDA approves next generation Aorflex delivery system


Lombard Medical announced on 21 June 2013 that the Aorflex delivery system has been approved for commercial use in the USA by the FDA. The Aorflex delivery system is the company’s next generation delivery system for its Aorfix stent graft, which was approved by the FDA in February 2013 (along with the previous generation delivery device) for the endovascular repair of abdominal aortic aneurysms. 

Aorfix is the only device licensed in the USA to treat abdominal aortic aneurysms with neck angulations up to 90 degrees. According to Lombard, this is a key advantage over other currently available stent grafts.  The company intends to launch Aorfix with Aorflex in the USA in H2 2013; a coordinated launch event will take place at the VEITHsymposium in New York in November 2013.

The Aorflex delivery system has been commercially available in Europe since April 2012 and has received positive feedback from clinicians. Aorflex offers a range of clinical benefits over the original delivery system aimed at improving the overall ease of use of the Aorfix stent graft, including:

  • Smoother introduction of the delivery system into blood vessels through the use of a hydrophilic coating
  • Greater deployment control with exceptional one-to-one torque 
  • X-ray marker to give positional feedback to physicians
  • Reduced deployment forces

The submission for the approval of the Aorflex delivery system was made to the FDA by the company in April 2013 and approval has been granted in two months.

Lombard Medical recently raised £20.9 million net of expenses through a Placing, Subscription and Offer to qualifying participants of shares.  These funds, together with the company’s existing cash resources of £15.2 million (as of 30 April 2013), will be used, in part, to launch Aorfix in the USA where the company is currently building its own marketing infrastructure and direct sales force. Initially Lombard Medical is targeting the 300 centres which perform approximately 50% of the US EVAR operations. 

CEO of Lombard Medical Technologies, Simon Hubbert, commented: “This is an exciting time in the history of the Company as we prepare for the US launch of Aorfix, our differentiated stent graft for the treatment of abdominal aortic aneurysms. 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. 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.”