Minos™ Completed Patient Enrollment of Pre-market Clinical Trials
18 Sept 2016
Shanghai, China - Minos™ Ultra Low Profile Abdominal Aortic Aneurysm ("AAA") Stent-Graft and Delivery System ("Minos™ Ultra Low Profile AAA Stent-Graft"), in-house developed by MicroPort Endovascular (Shanghai) Co., Ltd. ("MicroPort® Endovascular"), completed patient enrollment of pre-market clinical trials in assessing the safety and efficacy of Minos™ Ultra Low Profile AAA Stent-Graft in the treatment of AAA.
As the new-generation AAA stent-graft and delivery system, Minos™ Ultra Low Profile AAA Stent-Graft is China's first and only device to have ultra low profile delivery system with 14F outer diameter. Minos™ Ultra Low Profile AAA Stent-Graft has unique advantages in treating tortuous neck, short neck and narrow introducing artery as its requirement for introducing femoral artery diameter is as low as 5mm, and can appropriate tortuous vascular.
According to documents and statistics, many AAA patients have underlying diseases such as hypertension and arteriosclerosis, and a majority of them suffer from common iliac artery or external iliac artery calcification, tortuosity, stenosis, even total occlusion. Failure of introducing the delivery system is the most common obstacle in AAA endovascular (EVAR) exclusion surgery. Currently, the outer diameter of delivery sheath of other domestic brand ranges from 20-24F (6.5-8mm), suited for introducing femoral artery larger than 7mm, and when used in slight narrow femoral artery, balloon dilation or bare stent implantation is needed before introducing the stent-graft system, with high failure risk. With the outer diameter of delivery sheath of Minos™ Ultra Low Profile AAA Stent-Graft and its limb stent-graft as low as 14F (<5mm) and 12F(<4mm)respectively, the device lowers the surgical requirement for introducing femoral artery, suitable for introducing femoral artery with diameter larger than 5mm. MicroPort® Endovascular President Zhenghua Miao said:" The results of clinical researches show that for patients with thin, calcified and narrow common iliac artery, the delivery system of Minos™ Ultra Low Profile can be introduced without dilation, making it possible for patients who are not suitale for AAA endovascular (EVAR) exclusion surgery to receive minimally invasive surgical treatment. We are looking forward to the market launch of Minos™ Ultra Low Profile AAA Stent-Graft in China to serve more local patients .”