Lombard's stent graft study shows no endoleaks after 12 months

By Lisa Kerner

Erie, Pa., April 12 - Lombard Medical Technologies PLC said 12-month follow up data of 24 trial patients showed no endoleaks, fracture, migration or kinking in the company's Aorfix stent graft.

The results were presented at the 28th Charing Cross International Symposium at Imperial College, London.

"Aorfix will make a real contribution to the development of stent graft placement in abdominal aortic aneurysm by offering less risk and trauma to a wider range of patients than ever before, more clinical choices to medical practitioners and improved cost-effectiveness of this procedure," executive chairman Alistair Taylor said in a company news release.

Lombard said Aorfix has been used in more than 130 patients worldwide, with several abdominal aortic aneurysm bifurcated stent grafts exceeding 24 months of implantation with no device-related adverse effects.

The company also reported that the National Institute for Health and Clinical Excellence issued a new interventional procedure guidance confirming the current evidence on the efficacy and short-term safety of stent graft placement in abdominal aortic aneurysm.

The institute also recommended that patients understand the risks of endovascular leaks, the possibility of secondary intervention and the need for lifelong follow-up, Lombard said.

Device-related endoleaks, the most common adverse event in three randomized controlled trials, occurred in 19% of patients within the first year. Stent migration was reported in 1% of patients, and stent-wire fracture happened in 3% of patients, both within the first year, the company said.

Abdominal and thoracic aortic aneurysms are the 13th largest cause of death in the United States, with the market estimated to be worth approximately $2 billion by 2010, the release stated.

London-based Lombard is a medical devices company developing stent grafts and other medical products for use in the treatment of vascular disease.

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