FDA clears new robotically helped surgical gadget for transvaginal hysterectomy
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- Source: U.S. Food and Drug Administration
- Date: 01 Mar,2021
The U.S. Food and Drug Administration has approved marketing of the Hominis Surgical System, a brand new robotically-assisted surgical device (RASD) that can help alleviate transvaginal hysterectomy in some patients. The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (elimination of one or both fallopian tubes and ovaries).
We are providing physicians and patients another minimally-invasive gynecologic surgical option for non-cancerous conditions. The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures.”
Binita Ashar, M.D., MBA, FACS, Director, Office of Surgical and Infection Control Devices, FDA’s Center for Devices and Radiological Health
RASD, sometimes known as robotic surgical devices or computer-assisted surgical apparatus, aren’t actually robots. The devices cannot perform surgery without direct human control. RASD enable a surgeon to use software and computer technology to control and move surgical instruments through one or more miniature ports (incisions or orifices) from the patient’s body and in a variety of surgical procedures or surgeries. RASD technology facilitates performing minimally-invasive operation and intricate tasks in confined areas in the body.
The transvaginal approach requires fewer incisions on the stomach compared to traditional 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 personnel to complete before operation of the device.
In addition to its evaluation of engineering and performance 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 attributes such as ages ranging from 37 to 79 years, body mass index in 17.6-40, and 63 percent of patients had different comorbidities, such as hypertension, 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 peak of the vagina (vaginal cuff) that is done as part of a hysterectomy.
The FDA reviewed the apparatus through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk apparatus of a new kind. Along with this authorization, the FDA is establishing special controls for devices of this kind, including requirements related to tagging and performance testing. When met, the specific controls, together with general controls, provide reasonable assurance of safety and effectiveness for devices of the type.
The FDA granted marketing authorization of the Hominis Surgical System to Memic Innovative Surgery Ltd..