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Medical device specialist gets go ahead that could prove lucractive

by Rachel Robson

As well as announcing the start of its pivotal US clinical trial for its EndoRefix endostapling device, medical device specialist Lombard Medical Technologies has been awarded FDA approval of the investigational device exemption (IDE) application for the trial to extend it into ten centres and enroll up to 95 patients.

EndoRefix is designed initially to provide fixation of endovascular stent grafts which treat abdominal aortic aneurysms (AAAs). AAAs are a balloon-like enlargement of the aorta which, if left untreated, can rupture and result in death. Around 1.7 million people have AAAs in the US, where it is the thirteenth largest cause of death. EndoRefix enables endovascularly tiny fasteners to be delivered and pushed through the wall of the stent graft as well as the wall of the aorta, keeping the stent graft in place.

Every year in the US, around 35,000 endovascular AAA procedures are carried out, and it is estimated that up to 10,000 of these could benefit from the extra fixation provided by EndoRefix. The product will be marketed by Medtronic in the US under the brand name Securant.

Lombard Medical will be paid $3 million upon FDA approval of the device in accordance with terms of the distribution and license agreements completed at the end of 2006. The trial extension is expected to have completed recruitment by the end of July and the clinical data is likely to be submitted to the FDA in September for market consideration that may be received by the end of this year.

Shares says: Solid progress which bodes well for the future.