NICE Guidelines Recommend Use Of Stent Grafts For Treatment Of AAA

March 2, 2009 at 11:00 am Leave a comment


Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company, welcomes guidance from the National Institute for Health and Clinical Excellence (NICE) which recommends the use of endovascular stent grafts to treat abdominal aortic aneurysms (AAAs), a dangerous ballooning of arteries that can lead to massive internal bleeding and death.



Under the recommendation from NICE, the stent grafts should be considered as an option for patients treated on the National Health Service (NHS) whose aneurysms are below the kidney and have not yet ruptured.




Gillian Leng, Deputy Chief Executive of NICE, commented:



“The independent committee carefully considered the evidence and concluded that, where appropriate, endovascular stent grafts offered a good use of NHS resources for unruptured infra-renal abdominal aortic aneurysms.”



Lombard’s lead product for the treatment of AAAs, Aorfix™, remains on track to complete recruitment for its pivotal US trial (PYTHAGORAS) in Q2 2009 with over 70% of the filing requirement of 160 patients recruited.



In Europe, following completion of the ARBITER II trial in September 2008, a submission has been made to the Company’s notified body, TÜV to widen the existing CE Mark approval for Aorfix™ to include patients with high-angle-neck aneurysms. Approval of this unique indication to treat patients with aneurysm neck-angulations of up to 90 degrees, which is anticipated in H1 2009, is expected to accelerate sales of Aorfix™ in Europe.



Aorfix™ has now been used in over 750 cases worldwide and the Company is collecting a growing body of good clinical data on the product through its Retrospective Aorfix™ Data Retrieval (RADAR) clinical registry that now contains follow-up data on 440 patients.



Brian Howlett, CEO of Lombard, commented:



“We welcome the recent guidelines from NICE which confirm the prevalence and seriousness of Abdominal Aortic Aneurysms, which if left untreated could lead to death. Following our recent successful fundraising, Lombard is well placed to complete recruitment of the pivotal US trial for Aorfix™ by the end of Q2 2009 and capitalise on the extended label claim for Aorfix™ in Europe which we expect to receive in H1 2009.”



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 1.7 million people have AAAs in the US where it is the 13th largest cause of death. The market for endovascular stent grafts for the treatment of AAA is currently worth over $600 million and is expected to grow to around a $1 billion by 2010. 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 headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA.



Further background on the Company can be found at http://www.lombardmedical.com.



Lombard Medical

[Via http://www.medicalnewstoday.com]

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