Robot-assisted Device Approved To Facilitate Transvaginal Hysterectomy

经阴道子宫切除术机器人辅助装置获批准

2021-03-02 21:30:28 RTTNews

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The U.S. Food and Drug Administration has approved the marketing of a new robotically-assisted surgical device that can facilitate transvaginal hysterectomy in certain patients using minimally-invasive surgical instruments. The Hominis Surgical System of Memic Innovative Surgery Ltd., the U.S. subsidiary of Israeli biotechnology company memic Ltd., has been granted marketing authorization for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries). The agency said this medical device can improve patient experiences and provide another option for physicians and patients for minimally-invasive gynecologic surgical procedure for non-cancerous conditions. Though the device is called RASD or computer-assisted surgical devices, these type of devices cannot perform surgery without direct human control. The device will enable a surgeon to use computer and software technology to control and move surgical instruments through one or more tiny incisions made in the patient's body. Basically, the RASD technology makes things easier to perform a minimally-invasive surgery and complex tasks in confined areas inside the body. For the approved indication of uterus removal, minimally-invasive surgical instruments are inserted through the vagina (transvaginal approach) and a video camera inserted laparoscopically through a small incision on the abdomen for visualization of the instruments inside the patient. The transvaginal approach requires fewer incisions on the abdomen compared to conventional laparoscopic hysterectomy. All inserted instruments are controlled by the surgeons using the Hominis Surgical System console in the operating room. Under the terms of the approval, the FDA requires the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff before performing any such procedure. The agency reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The approval was based on the evaluation of safety and effectiveness of the device in a clinical study of 30 patients undergoing transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions. All 30 procedures with the system were successfully completed. According to the FDA, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. For comments and feedback contact: editorial@rttnews.com Business News
美国食品和药物管理局批准了一种新的机器人辅助手术设备的上市,该设备可以方便某些患者使用微创手术器械进行阴式子宫切除术。 以色列生物技术公司Memic Ltd.的美国子公司Memic Innovative Surgery Ltd.的Hominis外科手术系统已获准销售,用于良性子宫切除术(非癌性情况下切除子宫)和输卵管卵巢切除术(切除一个或两个输卵管和卵巢)。 该机构表示,这种医疗设备可以改善患者的体验,并为医生和患者提供了一种非癌症情况下微创妇科手术的另一种选择。 尽管这种设备被称为RASD或计算机辅助手术设备,但这些类型的设备不能在没有人类直接控制的情况下进行手术。该设备将使外科医生能够使用计算机和软件技术,通过在患者体内所做的一个或多个微小切口来控制和移动外科器械。 基本上,RASD技术使得在身体内部的封闭区域进行微创手术和复杂的任务变得更加容易。 对于经批准的子宫切除指征,通过阴道(经阴道入路)插入微创手术器械,并在腹腔镜下通过腹部的一个小切口插入摄像机,以便对患者体内的器械进行可视化。 与传统的腹腔镜子宫切除术相比,经阴道入路在腹部需要较少的切口。所有插入的器械由外科医生使用手术室的Hominis外科系统控制台控制。 根据批准条款,FDA要求制造商在实施任何此类手术之前,为外科医生和手术室工作人员制定并提供一个全面的培训计划。 该机构通过从头上市前审查途径对该设备进行了审查,这是一种针对新型低至中等风险设备的监管途径。 这项批准是基于对30例接受经阴道子宫全切并输卵管卵巢切除术或良性输卵管切除术的患者的临床研究的安全性和有效性的评估。该系统的30个程序全部顺利完成。 根据FDA的规定,特殊控制措施与一般控制措施一起,为这类设备的安全性和有效性提供了合理的保证。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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