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Robot-assisted Device Approved To Facilitate Transvaginal Hysterectomy

fda march02 lt

The U.S. Food and Drug Administration has approved the marketing of a new robotically-assisted surgical device (RASD) 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.

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