Lombard Medical Technologies announced on 15 February 2013 that Aorfix has been approved for commercial sale in the USA by the FDA. Aorfix is the company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms. Data from the US PYTHAGORAS trial of Aorfix, has demonstrated that Aorfix can successfully treat a larger patient population than competing devices, including both standard and difficult to treat cases of abdominal aortic aneurysm.
The US approval for Aorfix includes a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Aorfix is now the only endovascular stent graft licensed in the USA for use in more challenging cases with neck angulations greater than 60 degrees. Independent market research suggests that the US market for the repair of abdominal aortic aneurysms is worth over US$600 million per annum, is forecast to grow at approximately 8% per annum, and that up to 30% of all patients have some tortuosity either at the neck of the aneurysm or in the iliac arteries. It is to this segment of patients that Aorfix is targeted with its uniquely flexible design. In Europe Aorfix is already licensed to treat neck angulations of up to 90 degrees.
The PYTHAGORAS trial of Aorfix is the largest prospective controlled study, to date, of stent grafting in patients with highly angled aortas. Two hundred and eighteen patients at risk of aneurysm rupture were recruited in the trial. The study included 151 patients with neck angles greater than 60 degrees and 67 patients with neck angles less than 60 degrees. No aneurysms expanded in patients with neck angles less than 60 degrees and just 1.8% expanded in the patients with high neck angles, comparing favourably with the results of other devices in normal, less tortuous anatomy.
The approval of Aorfix triggers receipt of the c £14.1m Second Tranche of the two tranche placing and subscription announced by the company on 20 April 2011. Funds from the Second Tranche will be used to launch Aorfix in the USA through the company’s own direct sales force. In addition to building the US sales and marketing infrastructure, funds from the Second Tranche will also be used to expand production capacity to meet anticipated demand for the Aorfixstent graft, complete the planned extension of stent graft sizes and develop the next generation, lower profile delivery device.
US approval of Aorfix also triggers the company’s ability to draw down US$2.5m from the US$5m loan facility granted by its exclusive distribution partner in Japan, Medico’s Hirata. Medico’s Hirata is a leading supplier and developer of medical device products in Japan, with the sales infrastructure to maximise the potential of Aorfix in this important market. Lombard Medical continues to work with its partner to achieve Aorfix approval in Japan, which it anticipates will be in 2014.
Mark Fillinger of Dartmouth Hitchcock Medical Centre, New Hampshire, USA, principal investigator for the Aorfix trial, commented: “Having seen the benefits of using Aorfix in patients first hand, I am very pleased that the device is now available to treat patients in the USA. Aorfix allows a minimally invasive repair to be performed in abdominal aortic aneurysms with complicated highly-angulated aortic necks. This addresses a clear unmet medical need, as there are no other devices in the USA approved for use in 60-90 degree aortic necks. These patients would otherwise require open surgery, which is more invasive and higher risk, yet many of these patients are poor candidates for open repair.”
CEO of Lombard Medical Technologies, Simon Hubbert, commented: “FDA approval of Aorfix is a major milestone for the company and sets the stage for the next chapter in the company’s growth. I would like to thank all of our employees, investigators and clinical advisors for their support and hard work, without which development and approval of Aorfix would not have been possible. Aorfix is now the only stent graft approved in the USA to treat abdominal aortic aneurysms with neck angulations up to 90 degrees, a key advantage over other currently available stent grafts. We look forward to launching Aorfix in the USA through our own sales force and are confident of securing a meaningful share of this growing market.”