Further Positive Aorfix™ Data Reported at CIRSE and TCT
Dr Hardman presented data from Lombard Medical’s Retrospective Aorfix™ Data Retrieval (“RADAR”) voluntary registry. At the time of the analysis RADAR contained data on 753 implants out of approximately 1,000 performed to date worldwide. The data for those patients where follow-up information was available, continued to compare favourably with published data on the use of other stent grafts:
| Aorfix™ (September 2009) | |
| All cause 30-day mortality (of those fit for open surgery) | 1.59% (n=753) |
| Stent migration at 12 months | 0% (n=461) |
| Wire fracture at 12 months | < 0.25% (n=461) |
| Graft limb occlusion at 12 months | < 0.25% n=461) |
| Aneurysm rupture at 3 years | 0.9%* (n=106) |
* Occurred with a uni-iliac device that is no longer commercially available and in a patient who opted not to undergo further intervention.
Endoleak rates at one year were presented for both normal and high-angle-neck aneurysms with the incidence of type 1 endoleaks being 1.3% (n=151) and 3.8% (n=104) respectively, demonstrating that Aorfix™ maintains a good proximal seal even in patients with tortuous anatomy that cannot be treated with any other licensed stent graft.
Dr Hardman also presented the results of the ARBITER 2 study that supported approval in Europe of the unique label claim for Aorfix™ received in June 2009, to treat patients with high-angle-neck aneurysms of up to 90 degrees. The study was of 30 patients with aneurysm neck-angles of 70-90° (mean 79°). A third of patients had severely tortuous iliac arteries. The results showed that Aorfix™ was:
- Successfully inserted in nearly all cases but for one early mortality due to misplacement of the graft resulting in occlusion of the SMA (Superior Mesenteric Artery).
- No graft related complications or endoleaks reported at one month.
- No graft related complications reported at six months and a late endoleak rate of 7% represented two minor type 1a leaks that did not result in expansion of the aneurysm sac or the requirement for further intervention to date.
Dr Hardman commented:
“The RADAR patient cohort has revealed that Aorfix™ has good clinical outcomes in terms of clinical events, mortality rate, endoleaks, migration and fracture up to three years after insertion along with a very low limb occlusion rate. The ARBITER 2 data is also encouraging and demonstrates the safety profile and good clinical outcomes of Aorfix™ in challenging anatomy.”
Echoing the earlier presentation at CIRSE, Prof Cremonesi also presented the RADAR data to the TCT audience. He emphasized that there were no significant differences in operative
risk factors, such as blood loss and procedure time between high angle and low angle cases, underlining the success of Aorfix™ in extending EVAR surgery to this group of patients.
During the well attended TCT session, Dr Bill Gray (New York Presbyterian Hospital) illustrated the need for a flexible stent graft in highly tortuous aortic anatomy. Dr Mark Fillinger (Lebanon, NH), Principal Investigator of the US study of Aorfix™ described the strengths of the implant from his own experience. He said: “The Pythagoras study is concentrating on the most challenging anatomy seen in AAA surgery; the Company must be very confident in their device to design the study in this way.” Of several highly challenging cases illustrated, he concluded that: “Aorfix™ is the only implant that would have worked in these anatomies”. Questioned by Bill Gray about the availability of full results of the Pythagoras study, Dr Fillinger added: “We have more than 100 high angle cases recruited and need to submit 120. We should have all the data for submission to the FDA and publication by the end of 2010.”
“Reporting strong clinical data from our RADAR database at these major international congresses is an important means of informing clinicians of the excellent efficacy of Aorfix™ in both normal and tortuous anatomy. The clinical need for Aorfix™ was clearly annunciated at TCT and we are excited that completion of recruitment is now in sight.”
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Simon Neathercoat, Non-executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: 020 7831 3113
Jonathan Birt / Susan Quigley
Nomura Code Tel: 020 7776 1200
Juliet Thompson / Richard Potts
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAAs), a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Approximately 4.5 million people are living with AAA in the developed world and each year 600,000 new cases are diagnosed. The market for endovascular stent grafts for the treatment of AAA is currently worth over $800 million and is expected to grow to around $1.6 billion by 2015. Aorfix™ is currently being commercialised in the EU, with a pivotal clinical trial ongoing in the USA.
The Company’s Polymer Coatings Division has developed a novel hydrophilic surface treatment to reduce friction on catheters called GlideMax™, which is available for licensing, and is using its polymer coating technology in a number of research collaborations developing novel products for the $5 billion drug-eluting stent market.
The Company is headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA.
Further background on the Company can be found at www.lombardmedical.com.