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FDA Approves Next Generation Aorflex Delivery System

Mon, 06/24/2013 - 10:59am
Lombard Medical Technologies

Lombard Medical Technologies PLC (AIM: LMT), the specialist medical technology company focused on innovative vascular products, today announces that the Aorflex™ delivery system has been approved for commercial use in the US by the Food and Drug Administration (“FDA”). The Aorflex™ delivery system is the Company’s next generation delivery system for its unique Aorfix™ stent graft, which was recently approved by the FDA in February 2013 (along with the previous generation delivery device) for the endovascular repair of abdominal aortic aneurysms ("AAAs"). Aorfix™ is the only device licensed in the US to treat AAAs with neck angulations up to 90 degrees, a key advantage over other currently available stent grafts. The Company intends to launch Aorfix™ with Aorflex™ in the US in H2 2013; a coordinated launch event will take place at the VEITH symposium in New York City 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 US where the Company is currently building its own marketing infrastructure and direct sales force. Initially Lombard Medical is targeting the c.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 AAAs that present with more challenging anatomies.”

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