FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy

FDAThe U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries).

"We are providing physicians and patients another minimally-invasive gynecologic surgical option for non-cancerous conditions," said Binita Ashar, M.D., MBA, FACS, director of the Office of Surgical and Infection Control Devices in the FDA's Center for Devices and Radiological Health. "The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures."

RASD, sometimes referred to as robotic surgical devices or computer-assisted surgical devices, are not actually robots. The devices cannot perform surgery without direct human control. RASD enable a surgeon to use computer and software technology to control and move surgical instruments through one or more tiny ports (incisions or orifices) in the patient’s body and in a variety of surgical procedures or operations. RASD technology facilitates performing minimally-invasive surgery and complex tasks in confined areas inside the body.

To remove the uterus, the Hominis Surgical System uses minimally-invasive surgical instruments 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. During the procedure, surgeons in the operating room control the instruments from the Hominis Surgical System console. The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device.

In addition to its assessment of performance and engineering testing, the FDA evaluated safety and effectiveness in a clinical study of 30 patients undergoing transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions, using the Hominis Surgical System. Patients had varying characteristics such as ages ranging from 37 to 79 years, body mass index from 17.6-40, and 63% of patients had different comorbidities, such as high cholesterol, osteoporosis or high blood pressure. All 30 procedures with the Hominis Surgical System were successfully completed and there were no conversions to an open or other laparoscopic surgical approach. Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.

The FDA granted marketing authorization of the Hominis Surgical System to Memic Innovative Surgery Ltd.

About the U.S. Food and Drug Administration (FDA)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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