EN
登录

心血管介入设备开发商Cordis宣布Mynx Control静脉血管闭合装置获FDA批准

FDA Approves Cordis' Mynx Control Venous Vascular Closure Device

mpo-mag 等信源发布 2024-07-11 16:47

可切换为仅中文


Cordis has earned U.S. Food and Drug Administration (FDA) approval for its MYNX Control venous vascular closure device (VCD) for procedures with access sites from 6-12F.

Cordis的MYNX控制静脉血管闭合装置(VCD)已获得美国食品和药物管理局(FDA)的批准,用于6-12F进入部位的手术。

The MYNX Control venous VCD leverages Grip Technology, which is based on hydrophilic, bioinert polyethylene glycol (PEG). According to the company, the MYNX Control sealant resorbs three times faster than collagen-based sealants, and offers the fastest time to hemostasis of currently available venous closure devices..

MYNX Control静脉VCD利用Grip技术,该技术基于亲水性生物惰性聚乙二醇(PEG)。据该公司称,MYNX Control密封剂的再吸收速度是胶原基密封剂的三倍,并且为目前可用的静脉闭合装置提供了最快的止血时间。。

The company’s ReliaSeal trial, which compared manual compression vs. Mynx Control in cardiac ablation, met all clinical endpoints and achieved 100% procedure and device success. Results also showed Mynx Control achieved hemostasis in 2.1 minutes, compared to 11.4 minutes for manual compression.

该公司的ReliaSeal试验比较了手动压缩与Mynx控制在心脏消融中的作用,符合所有临床终点,并取得了100%的手术和设备成功。结果还显示,Mynx Control在2.1分钟内实现止血,而手动压迫则为11.4分钟。

Time to ambulation in the trial was 2.6 hours for Mynx Control and 5.14 hours for manual compression. Time to discharge eligibility was 3.1 vs. 5.5 hours, respectively.

。出院时间分别为3.1小时和5.5小时。

Cordis said it aims to launch the venous VCD in the U.S. in the upcoming months.

Cordis表示,计划在未来几个月在美国推出静脉VCD。

'MYNX CONTROL VENOUS VCD demonstrates Cordis' commitment to innovation and will offer immediate value to physicians and patients,' said Cordis VP of global marketing and strategy Chris Bingham. 'Cordis is building a robust portfolio of products across the coronary, peripheral and closure markets. We look forward to bringing transformative innovation to market, benefitting both patients and physicians.'.

Cordis全球营销和战略副总裁克里斯·宾厄姆(ChrisBingham)说:“MYNX CONTROL Vential VCD展示了Cordis对创新的承诺,将为医生和患者提供即时价值。”Cordis正在冠状动脉、外围和封闭市场建立强大的产品组合。我们期待着将变革性创新推向市场,使患者和医生都受益。”。