speX Support Catheter Obtained NMPA Registration Certificate
10 Nov 2020
Shanghai, China—The speX Support Catheter distributed by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec™) recently received a registration certificate from the National Medical Products Administration (NMPA).
The speX Support Catheter is used for access to peripheral vascular lesions. Used in conjunction with a guidewire, it is able to pass narrow occlusion in the peripheral vasculature, particularly useful in facilitating the opening of extended occlusion in the lower extremities. speX is available in three lumen diameters of 0.014, 0.018, and 0.035 in, and in lengths at 50, 90, 135, and 150 cm, compatible with any type of guidewires or sheaths. The tip of the catheter can be shaped to desired angles to accommodate different vascular anatomy based on clinical needs. The hydrophilic coating and braided composite ensure better pushability, which facilitates catheter advancement or retraction in tortuous vessels and crossing the occlusion.
Peripheral arterial occlusive disease (PAOD) often refers to atherosclerotic occlusion of the lower extremity arteries that manifests as chronic ischemic diseases, such as intimal thickening, calcification, and secondary thrombosis, further leading to narrowing and occlusion of the arteries, the most prevalent symptom in patients with PAOD. In the past decade, significant accomplishments have been made in the treatment of PAOD through endovascular techniques. Endoluminal treatment of occlusions of the lower extremities requires vascular access, with the aid of a guidewire to reach the lesion. Vascular access is often the most time-consuming step of the procedure, especially in situations where only the guidewire is used to access the occlusion, in which case guidewire deformation or penetration into subendothelium often occurs. The use of a support catheter provides additional support for the guidewire, significantly improving the success rate of accessing occlusions, shortening procedure time, and relieving patient discomfort during the procedure.
Zhenghua Miao, President of Endovastec™, said, “Endovastec™ has been committed to providing patients with integrated solutions for peripheral vascular interventions, and has already marketed a series of products such as drug-coated balloon dilatation catheters, peripheral vascular stent systems and peripheral vascular balloon dilatation catheters, etc. The registration of the speX Support Catheter further enriches the product line of Endovastec™ and improves the company’s product portfolio in the field of peripheral vascular interventions. In the future, Endovastec™ will continue to innovate and provide more inclusive medical solutions in the field of aortic and peripheral vascular intervention for the benefit of patients.”