Lombard Medical gets IDE approval to start clinical trial for stent graft Aorfix

By Elaine Rigoli

Tampa, Fla., Feb. 17 - Lombard Medical Technologies plc reported Friday that it has received Investigational Device Exemption approval for a clinical trial to be held for Aorfix, an endovascular stent graft used in the treatment of abdominal aortic aneurysms.

The first part of the trial, which begins this quarter in the United States, will be conducted in up to 20 centers and will involve more than 250 patients diagnosed with abdominal aortic aneurysms and with neck angulations of 60° or less being treated with Aorfix.

These will be compared with a control group of 110 patients unsuitable for endovascular graft therapy, who will receive conventional open surgery. Recruitment is expected to take approximately 12 to 15 months and patients are followed for up to a year, which includes CT imaging to check for graft integrity and endoleaks.

Lombard will receive revenues for the clinical trials in the United States and once recruitment for the trial has been completed, the FDA will permit the use of Aorfix, pre-approval, in the indications covered by the IDE in those centers that participated in the trial, according to a company news release.

Principal investigator for the study is Dr. Ron Fairman of the University of Pennsylvania. Fairman previously served as principal investigator for a Medtronic thoracic aortic aneurysm stent study.

For the second part of the trial, a supplemental Investigational Device Exemption will also be filed with the FDA part-way through the trial for approval of a third arm to be added to the study to include 110 patients with a neck angulation of greater than 60°.

There is currently no endovascular stent graft approved for use in patients with such a high neck angulation in the United States, the release stated.

"There is a large opportunity in the AAA [abdominal aortic aneurysms] market for a second generation stent graft, and we believe that Aorfix is the only one that addresses the limitations of existing devices," said Lombard executive chairman Alistair Taylor, in a company statement.

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

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