ReactTM 71 Catheter一次性颅内血栓抽吸导管

Brand	EV3(医伟司安)
Manufacturer	Micro Therapeutics, Inc. DBA ev3 Neurovascular麦克罗医伟司安神经血管医疗股份有限公司
Production Address	9775 Toledo Way, Irvine, CA 92618, United States of America
Intended Use	Used for delivery of interventional devices in peripheral and intracranial neurovascular vessels. Also applicable for recanalization of large intracranial vessel occlusion (internal carotid artery, middle cerebral artery – M1 and M2 segments, basilar artery, and vertebral artery) in patients with acute ischemic stroke, within 8 hours of symptom onset. Patients who have failed intravenous tissue-type plasminogen activator (IV t-PA) or IV t-PA treatment are candidates for this therapy.用于在外周和颅内神经血管内输送介入器材。也适用于对颅内大血管阻塞（颈内动脉、大脑中动脉-M1段和M2段、基底动脉和椎动脉内）继发急性缺血性脑卒中的患者进行血管再通，而且必须在症状发作的8小时内。不能使用静脉组织型纤溶酶原激活物(IVt-PA)或IV t-PA治疗失败的患者是该治疗的人选
References	REACT-71
Manufacturer’s Website	https://europe.medtronic.com/xd-en/healthcare-professionals/products/neurological/revascularization-stroke/react-catheters.html
Product Brochure
Registration Certificate	国械注进20203030412

Brand

The product is a single lumen, elastic catheter made of different hardness composite materials, with a Y-shaped introducer sheath attachment. The inner layer of the catheter is made of polytetrafluoroethylene and Engage polyolefin elastomer. The catheter contains a reinforcement layer composed of coils and braided layers, made of nitinol alloy. The outer layer of the catheter includes polyamide, polyether-block-amide, and polyolefin elastomer. The distal end of the catheter has a Surmodics Serene coating and a radiopaque platinum-iridium marker. Ethylene oxide sterilization, for single-use only, with a shelf life of two years.

该产品是一根单腔、有弹性的、由不同硬度复合材料制成的导管,带有Y型导入鞘附件。导管内层材料是聚四氟乙烯和Engage聚烯烃弹性体。导管含有加固层，由线圈和编织层组成,材料是镍钛合金。导管外层材料包括聚酰胺、聚醚嵌段酰胺、聚烯烃弹性体等。导管远端带有Surmodics Serene涂层,并带有不透射线铂铱标记带。环氧乙烷灭菌,一次性使用,货架有效期两年。