CE Mark and conditional IDE approval received for second-generation EndoRefix™
London, UK, 22 October 2007 – Lombard Medical Technologies PLC (“Lombard Medical” or “the Company”), the specialist medical device company, today announces that it has received continued CE Mark approval for a reconfiguration of its endostapler, EndoRefix™ as well as conditional FDA approval of its investigational device exemptions (“IDE”) application for the product.
EndoRefix™ is designed initially to provide fixation of endovascular stent grafts which treat abdominal aortic aneurysms (“AAAs”). The device delivers percutaneously tiny fasteners (staples), which are pushed through both the wall of the stent graft as well as the wall of the aorta, to keep the stent graft firmly in place.
As well as including technical changes to aid manufacture, the revised product incorporates a new coating to the clip cartridge catheter that improves the controllability and performance of the device.
The conditional IDE approval allows the Company to contract with investigational centres and begin patient treatment enrolment at centres who have obtained their Investigational Review Board (“IRB”) approval of the protocol for the pivotal US trial. The conditions of approval require clarifications to the statistical analysis of study end points and a completed statistical analysis plan for product claims. Whilst providing these clarifications Lombard Medical will continue to develop the manufacturing process in conjunction with its contract manufacturer with the aim of receiving unconditional FDA approval of the IDE analysis plan and having scaled-up manufacture in time to start recruitment into the trial in early 2008. With receipt of this conditional IDE approval the Company is on course with its planned timetable for completion of the trial, submission for product approval and marketing of EndoRefix™ in the USA.
EndoRefix is the subject of a distribution agreement with Medtronic, Inc who will market the product under the brand name Securant™. In the USA, it is expected that Medtronic will launch the product soon after FDA approval whilst in Europe a limited launch will follow the successful conclusion of a small, ten-patient, clinical study, to be undertaken later this year, to evaluate the clinical utility of EndoRefix™ as an adjunctive procedure to endovascular AAA stent graft therapy. Medtronic plans to widen the European launch as further clinical experience of the product is gained during 2008.
Commenting on receipt of the CE Mark and conditional IDE approval, Brian Howlett, Chief Executive of Lombard Medical, said:
“We are delighted to have received both the continued CE Mark approval and conditional IDE approval for EndoRefix™ on schedule. These approvals bring us closer to Medtronic’s launch of this innovative product, with performance improvements over the original product, in both Europe and the USA.”
Enquiries:
Lombard Medical Technologies PLC Tel: 01235 750 800
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics Tel: 020 7831 3113
David Yates / John Gilbert
Nomura Code Tel: 020 7776 1200
Richard Potts
Notes to editors
About Lombard Medical
Lombard Medical Technologies is a medical devices company developing stent grafts and other medical products for use in the treatment of vascular disease. The Company’s lead product, Aorfix™, is a stent graft for the treatment of aortic aneurysms, a balloon-like enlargement of the aorta which, if untreated, may rupture and cause death. Abdominal and thoracic aortic aneurysms are the 13th largest cause of death in the US and the market is estimated to be worth approximately US$2 billion by 2010. Aorfix™ is currently being commercialised in the EU and US clinical trials are ongoing. The Company’s Polymer Coatings Division primarily develops polymer coatings for use in drug-eluting stents and has a number of research collaborations developing novel products for this $6bn market.
The Company, headquartered in Oxfordshire, with operations in Yorkshire, Ayrshire and Boston, USA employs over 100 people.
Further background on the Company can be found at www.lombardmedical.com.