FDA Authorizes First Robotically-Assisted Surgical Device

FDA Authorizes First Robotically-Assisted Surgical Device

The U.S. Food and Drug Administration (FDA) 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.”

Abdominal Hysterectomy

Abdominal hysterectomy is performed in the United States at a 3:1 ratio over vaginal hysterectomy, despite evidence that vaginal hysterectomy offers advantages over abdominal hysterectomy with regard to operative time, complication rates, recovery, return to daily activities, and overall costs of treatment.

In fact, the predominance of the abdominal approach may be based on factors other than clinical considerations, including resident training, use of limited or obsolete guidelines, greater third-party compensation for abdominal procedures, a presumption rather than a confirmation that pathology exists that contraindicates a vaginal approach, and misconceptions about the safety and cost of vaginal hysterectomy. A number of studies spanning several years demonstrate that the use of more systematic guidelines for selecting the route of hysterectomy results in a major shift toward the vaginal approach.

Evidence also shows that transvaginal hysterectomy is both feasible and optimum for types of patients who have long been considered inappropriate candidates for the vaginal route. New instrumentation facilitates the vaginal approach and contributes to improved hemostasis and decreased operative time. Included here is a step-by-step approach to determining appropriate candidates for the vaginal approach via assessment of access, uterus size, and extent of pathology.

Robotically-Assisted Surgical Device

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.

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