近日，微创心脉医疗科技（上海）有限公司（以下简称“微创心脉”）宣布已有18名患者入组Minos™ Ultra-low profile腹主动脉覆膜支架系统上市前临床研究，该临床研究用于评估Minos™ Ultra-low profile腹主动脉覆膜支架系统治疗肾下型腹主动脉瘤（AAA）的临床安全性和有效性。

Minos临床研究是一项多中心、前瞻性、非随机临床试验，将在中国的15个中心入组130例AAA患者。

本次临床试验主要研究者－上海复旦大学附属中山医院血管外科主任符伟国教授表示：“就目前而言，Minos™”覆膜支架的密封性能尤其出色，能有效地隔绝瘤体，而输送器的超低profile设计使术者能为更多患者开展微创伤的腹主动脉瘤支架型腔内修复术（EVAR），尤其是入路血管较细，原本不适合接受EVAR术的患者。

Minos™覆膜支架的裸支架上带有激光一体雕刻而成的倒钩，单丝编织而成的分支支架兼顾柔顺性和支撑性，覆膜支架整体稳定锚定于肾下腹主动脉和双侧髂动脉，重塑血流通道，有效而持久地隔绝动脉瘤。

Minos™覆膜支架系统将输送器的外径降低到14~16F，将EVAR适应症扩展到入路动脉狭窄而扭曲的患者，尤其是女性患者，而目前中国市场上腹主动脉支架系统的输送器外径均在18~24F之间。因此Minos™ Ultra-low profile腹主动脉覆膜支架系统的超低profile的特性是EVAR领域的一项重要突破，为患者和术者提供了更微创的治疗方法和更稳定持久的治疗效果。

以下为在Vascular News上发表的原文：

MicroPort Endovascular begins Minos abdominal aortic stent graft pre-market study

Mon Mar 30, 2015

MicroPort Endovascular has announced that18 patients have now been enrolled in a pre-market clinical study to assess theefficacy and safety of the company’s Minos ultra-low profile abdominal aorticstent graft system to treat infrarenal abdominal aortic aneurysms.

The pre-market clinical study is amulticentre, open-label, prospective, non-randomised study that will enrol upto 130 abdominal aortic aneurysm patients in 15 centres in China.

“Up until now, the Minos system has had an especially effectivesealing effect”, said the study’s principle investigator, Weiguo Fu, head ofthe Department of Endovascular Surgery at Fudan University Zhongshan Hospitalin Shanghai, China. “Its ultra-low profile design allows physicians to employthis less invasive procedure for many patients, especially those with smallervasculature who might otherwise be ineligible for endovascular aneurysmrepair.”

The stent graft of the Minos systemfeatures laser-cut hooks on the bare stent and strong but flexible limbsachieving a stable and upright position in the aorta, in order to reinforce thelower part of the aorta and to effectively exclude an aneurysm.

The system is indicated for endovasculartreatment of abdominal aortic aneurysms, with the outer diameter of theintegrated delivery system ranging from 14–16 French. This feature has expandedendovascular aneurysm repair to patients with small or tortuous femoral or iliacarteries, which is especially common in female patients. Existing endovascularaneurysm repair devices in China have system profiles ranging from 18–24French. MicroPort believes that the “ultra-low” profile nature of the Minossystem represents an innovation in the field, providing patients and physicianswith a less invasive treatment approach and a more durable efficacy for thetreatment of abdominal aortic aneurysms.