Endovastec™ Obtains NMPA Approval to Launch Minos™ Ultra-Low Profile Abdominal Aortic Aneurysm Stent Graft System

Shanghai, China - Shanghai MicroPort Endovascular MedTech Co., Ltd. (“Endovastec™”) has obtained registration certificate for its independently developed Minos™ Ultra-Low Profile Abdominal Aortic Aneurysm Stent Graft System (“Minos™ Stent Graft”) from National Medical Products Administration of China (“NMPA”) recently. Minos™ Stent Graft is the second of the Endovastec™ products to be successfully granted registration certificates from NMPA after entering the Special Review and Approval Procedure for Innovative Medical Devices (the “Green Path”).

An aortic aneurysm refers to an enlargement of the aorta, with the permanent localized enlargement exceeding 50% of the diameter of normal vessels. The disease results from a weakened, less elastic and gradually-bulging area on the wall of the aorta and is divided into thoracic aortic aneurysm (“TAA”) and abdominal aortic aneurysm (“AAA”) according to the positions of lesions. An increasingly aging population is putting more and more people at high risk of AAA. People who are over 60 years of age, male, smokers, and hypertension or heart disease patients run a high risk of AAA.

The AAA is prone to rupture that causes hemorrhage or even death. Therefore, the AAA should be effectively treated immediately after it is discovered. The endovascular abdominal aorta therapy with stent graft can effectively block the aneurysm and restore normal blood flow. The currently widely adopted endovascular aneurysm repair (EVAR) involves the placement of a stent graft within the aorta to block the high-pressure blood flow from the aneurysm wall, following the introduction of the stent graft with a specially designed delivery system through the femoral artery. Compared to the conventional open aortic surgery, the EVAR procedure has the advantages of small trauma, little blood loss, quick recovery, and short hospital stay, making it particularly applicable to high-risk AAA patients.

The AAA patients mostly have underlying diseases such as hypertension and arteriosclerosis, and most of them also suffer calcification, tortuosity, stenosis, and even total occlusion of common iliac artery or external iliac artery. Therefore, the most common challenge for EVAR in AAA is the access artery stenosis and tortuosity. Meanwhile, the short and tortuous neck anatomies in AAA may cause a series of complications such as stent graft migration and endoleak, which poses a long-term clinical challenge. As the new-generation AAA stent graft and delivery system independently developed by Endovastec™, Minos™ Stent Graft can be applied in the treatment of AAA with proximal neck length no less than 15mm. It is China’s only AAA stent graft product that features a 14F (<5mm) outer diameter of the delivery system on the basis of independent intellectual property. The product significantly eases EVAR’s requirements on artery access. Minos™ Stent Graft applies the core technologies that its main body is constructed from a laser-cut M-stent with integrated barbs and covered with seamless woven graft, and its iliac limbs are woven by a single wire in a spiraling pattern. The product can meet the needs for the endovascular repair of more AAA with complex anatomies and reduce the incident rate of common complications such as stent graft migration, endoleak, and limb occlusion, so as to further lower the risk of long-term reintervention. Minos™ Stent Graft features a three-piece design that enables in situ customization during procedure.

Endovastec™ President Zhenghua Miao said, “The launch of Minos™ Stent Graft will provide a better solution for the patients diagnosed with the AAA with complex anatomies and especially benefit those with access artery stenosis and tortuosity. Endovastec™ will follow a R&D credo of relentless innovation to create more innovative products and benefit patients.”