MicroPort Endovascular has announced that 18 patients have now been enrolled in a pre-market clinical study to assess the efficacy and safety of the company’s Minos ultra-low profile abdominal aortic stent graft system to treat infrarenal abdominal aortic aneurysms.
The pre-market clinical study is a multicentre, open-label, prospective, non-randomised study that will enrol up to 130 abdominal aortic aneurysm patients in 15 centres in China.
“Up until now, the Minos system has had an especially effective sealing effect”, said the study’s principle investigator, Weiguo Fu, head of the Department of Endovascular Surgery at Fudan University Zhongshan Hospital in Shanghai, China. “Its ultra-low profile design allows physicians to employ this less invasive procedure for many patients, especially those with smaller vasculature who might otherwise be ineligible for endovascular aneurysm repair.”
The stent graft of the Minos system features laser-cut hooks on the bare stent and strong but flexible limbs achieving a stable and upright position in the aorta, in order to reinforce the lower part of the aorta and to effectively exclude an aneurysm.
The system is indicated for endovascular treatment of abdominal aortic aneurysms, with the outer diameter of the integrated delivery system ranging from 14–16 French. This feature has expanded endovascular aneurysm repair to patients with small or tortuous femoral or iliac arteries, which is especially common in female patients. Existing endovascular aneurysm repair devices in China have system profiles ranging from 18–24 French. MicroPort believes that the “ultra-low” profile nature of the Minos system represents an innovation in the field, providing patients and physicians with a less invasive treatment approach and a more durable efficacy for the treatment of abdominal aortic aneurysms.
