European Label Claim Extension for Aorfix™ to Treat Patients with High-angle-neck Aneurysms
London, UK, 4 June 2009 – Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company, announces that it has received European approval to extend its existing indication to treat abdominal aortic aneurysms (“AAAs”) with neck angulations up to and including 90° (currently 65°).
This unique indication extends the use of endovascular treatment to patients with challenging anatomy that are often at risk in open surgical procedures due to their age or co-morbidities.
Brian Howlett, CEO of Lombard Medical, commented:
“This significant additional indication extends the use of endovascular repair of abdominal aortic aneurysms to a group of patients who may not have any other treatment options. Furthermore, it demonstrates the versatility of Aorfix™ in treating a broad spectrum of patients and achieving good clinical outcomes, regardless of tortuosity of the vascular anatomy.”
The approval was received from Technischer Überwachungsverein (“TÜV”), Lombard Medical’s designated regulatory notified body, and follows submission of clinical data from a study to assess Aorfix™ in the treatment of AAAs with infra-renal neck angulations of between 60° and 90°. The technical results submitted demonstrated that Aorfix™ had a low occurrence of device deployment events and that the placement of the device in AAAs with high-angled infra-renal necks was well tolerated. Initial performance, as measured by the incidence of endoleaks at 30 days, was superior to that of the comparator historical data set.
For patients who had their 30-day and 6-month follow-ups, there were no reports of device rupture, migration, stent fracture, loss of patency, vessel perforation, significant obstruction or conversion to open repair. Furthermore, all patients reviewed after six months were found to have a stable or shrinking aneurysm sac indicating that the aneurysm was under control. The study report concluded that Aorfix™ in the treatment of high-angle-neck aneurysms was safe and effective in the short-term.
The clinical data from the Arbiter II study complements that from Lombard Medical’s Retrospective Aorfix™ Data Retrieval (“RADAR”) voluntary registry. Recently presented RADAR data from a wide spectrum of patients, summarised in the table below, demonstrates that Aorfix™ has the ability to treat successfully both standard and severely-angled AAAs with equally good results.
| Feature | Neck angle < 60° | Neck angle > 60° |
| Eligible cases with 1 year follow-up | 111 | 73 |
| Mean aneurysm neck angle | 29° | 80° |
| Stent migration at 12 months | 0.0% | 0.0% |
| Wire fracture at 12 months | 0.0% | 0.0% |
| Type 1 endoleaks at 12 months | 0.9% | 1.4% |
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